Trial Outcomes & Findings for Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (NCT NCT00499590)

NCT ID: NCT00499590

Last Updated: 2014-10-06

Results Overview

avoidance of 3 or more lines of vision loss

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 338 participants
• Primary outcome timeframe: week 60
• Results posted on: 2014-10-06

Participant Flow

Participant milestones

Measure	Lucentis® Lucentis® (0.5mg) every 4 weeks. ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.	Bevasiranib 8 Weeks Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks	Bevasiranib 12 Weeks Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
Overall Study STARTED	113	112	113
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	113	112	113

Reasons for withdrawal

Measure	Lucentis® Lucentis® (0.5mg) every 4 weeks. ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.	Bevasiranib 8 Weeks Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks	Bevasiranib 12 Weeks Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
Overall Study Study Terminated	112	112	112
Overall Study Not treated	1	0	1

Baseline Characteristics

Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD

Baseline characteristics by cohort

Measure	Lucentis n=113 Participants Lucentis® (0.5mg) every 4 weeks. ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.	Bevasiranib 8 Weeks n=112 Participants Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks	Bevasiranib 12 Weeks n=113 Participants Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks	Total n=338 Participants Total of all reporting groups
Age, Continuous	77.6 years n=5 Participants	77.2 years n=7 Participants	78.3 years n=5 Participants	77.7 years n=4 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	72 Participants n=7 Participants	59 Participants n=5 Participants	211 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	40 Participants n=7 Participants	54 Participants n=5 Participants	127 Participants n=4 Participants
Region of Enrollment United States	61 participants n=5 Participants	59 participants n=7 Participants	64 participants n=5 Participants	184 participants n=4 Participants
Region of Enrollment Austria	4 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	13 participants n=4 Participants
Region of Enrollment Canada	8 participants n=5 Participants	10 participants n=7 Participants	5 participants n=5 Participants	23 participants n=4 Participants
Region of Enrollment France	22 participants n=5 Participants	24 participants n=7 Participants	20 participants n=5 Participants	66 participants n=4 Participants
Region of Enrollment Israel	9 participants n=5 Participants	7 participants n=7 Participants	6 participants n=5 Participants	22 participants n=4 Participants
Region of Enrollment Italy	5 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	9 participants n=4 Participants
Region of Enrollment Portugal	3 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	11 participants n=4 Participants
Region of Enrollment Spain	1 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants	10 participants n=4 Participants

PRIMARY outcome

Timeframe: week 60

Population: Zero participants analyzed due to early termination of the study.

avoidance of 3 or more lines of vision loss

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 60

Population: Zero participants analyzed due to early termination of the study.

Outcome measures

Outcome data not reported

Adverse Events

Lucentis

Serious events: 26 serious events

Other events: 71 other events

Deaths: 0 deaths

Bevasiranib 8 Weeks

Serious events: 28 serious events

Other events: 85 other events

Deaths: 0 deaths

Bevasiranib 12 Weeks

Serious events: 33 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lucentis n=112 participants at risk Lucentis® (0.5mg) every 4 weeks. ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.	Bevasiranib 8 Weeks n=112 participants at risk Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks	Bevasiranib 12 Weeks n=112 participants at risk Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
Blood and lymphatic system disorders Anaemia	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Cardiac disorders Atrial fibrillation	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Cardiac disorders Myocardial infarction	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Cardiac disorders Acute myocardial infarction	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Cardiac disorders Angina pectoris	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Cardiac disorders Coronary artery disease	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Ear and labyrinth disorders Vertigo	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Visual acuity decreased	4.5% 5/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	6.2% 7/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	8.9% 10/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Endophthalmitis	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	3.6% 4/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Uveitis	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	1.8% 2/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Vitritis	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	2.7% 3/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Vitreous haemorrhage	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	1.8% 2/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Cataract	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Corneal oedema	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Hyphaema	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Iridocyclitis	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Macular degeneration	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Punctate keratitis	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Gastrointestinal disorders Abdominal pain upper	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Gastrointestinal disorders Intestinal obstruction	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Gastrointestinal disorders Pancreatitis	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
General disorders Asthenia	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Immune system disorders Anaphylactic reaction	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Infections and infestations Pneumonia	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	1.8% 2/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Infections and infestations Bronchitis	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Infections and infestations Gastroenteritis viral	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Infections and infestations Keratitis herpetic	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Injury, poisoning and procedural complications Fall	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Injury, poisoning and procedural complications Hip fracture	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Injury, poisoning and procedural complications Injury	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Injury, poisoning and procedural complications Upper limb fracture	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Investigations Heart rate irregular	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Metabolism and nutrition disorders Dehydration	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Musculoskeletal and connective tissue disorders Back pain	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Musculoskeletal and connective tissue disorders Arthritis	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Musculoskeletal and connective tissue disorders Intervertebral disc protusion	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	1.8% 2/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Nervous system disorders Cerebrovascular accident	1.8% 2/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	1.8% 2/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Nervous system disorders Syncope	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	1.8% 2/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Nervous system disorders Transient ischemia attack	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	1.8% 2/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Nervous system disorders Carotid artery stenosis	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Nervous system disorders Dementia	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Nervous system disorders Headache	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Renal and urinary disorders Renal failure chronic	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	1.8% 2/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Vascular disorders Deep vein thrombosis	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Vascular disorders Hypotension	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Vascular disorders Thrombosis	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.89% 1/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	0.00% 0/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.

Other adverse events

Measure	Lucentis n=112 participants at risk Lucentis® (0.5mg) every 4 weeks. ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.	Bevasiranib 8 Weeks n=112 participants at risk Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks	Bevasiranib 12 Weeks n=112 participants at risk Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
Eye disorders Retinal haemorrhage	9.8% 11/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	14.3% 16/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	19.6% 22/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Visual acuity reduced	3.6% 4/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	7.1% 8/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	10.7% 12/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Conjunctival haemorrhage	8.9% 10/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	8.0% 9/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	11.6% 13/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Vitreous detachment	7.1% 8/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	9.8% 11/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	8.9% 10/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Vitreous floaters	8.0% 9/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	8.9% 10/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	7.1% 8/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Eye pain	5.4% 6/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	6.2% 7/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	10.7% 12/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Macular degeneration	4.5% 5/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	6.2% 7/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	8.0% 9/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Eye disorders Cataract	7.1% 8/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	3.6% 4/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	5.4% 6/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Infections and infestations Nasopharyngitis	6.2% 7/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	5.4% 6/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	4.5% 5/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
Investigations Intraocular pressure increased	2.7% 3/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	6.2% 7/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.	8.9% 10/112 • Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months. Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.

Additional Information

Jane Hsiao, PhD, MBA

OPKO Health, Inc.

Phone: 305-575-6004

Email: jhsiao@opko.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place