Trial Outcomes & Findings for High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia (NCT NCT01205035)

NCT ID: NCT01205035

Last Updated: 2015-04-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Baseline to 12 months
• Results posted on: 2015-04-10

Participant Flow

Participant milestones

Measure	Observation Observation; No treatment given	Intravitreal Ranibizumab 2.0mg Initial dose 2.0mg switched to 1.0mg at near conclusion of study. ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
Overall Study STARTED	3	3
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Observation Observation; No treatment given	Intravitreal Ranibizumab 2.0mg Initial dose 2.0mg switched to 1.0mg at near conclusion of study. ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia

Baseline characteristics by cohort

Measure	Observation n=3 Participants Observation; No treatment given	Intravitreal Ranibizumab 2.0mg n=3 Participants Initial dose 2.0mg switched to 1.0mg at near conclusion of study. ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections	Total n=6 Participants Total of all reporting groups
Age, Continuous	68 years n=5 Participants	65 years n=7 Participants	66.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 months

Outcome measures

Measure	Observation n=1 Participants Observation; No treatment given	Intravitreal Ranibizumab 2.0mg n=3 Participants Initial dose 2.0mg switched to 1.0mg at near conclusion of study. ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
Visual Acuity Change From Baseline to Month 12 of the Study	0.1 LogMAR Unit Interval 0.1 to 0.1	-0.05 LogMAR Unit Interval -0.12 to 0.0

SECONDARY outcome

Timeframe: Baseline to 6 months and baseline to 9 months

Outcome measures

Measure	Observation n=1 Participants Observation; No treatment given	Intravitreal Ranibizumab 2.0mg n=3 Participants Initial dose 2.0mg switched to 1.0mg at near conclusion of study. ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
Change in Visual Acuity From Baseline to Month 6 and From Baseline to 9 Months Baseline to 6 month	0.04 LogMAR Unit Interval 0.04 to 0.04	-0.10 LogMAR Unit Interval -0.2 to -0.02
Change in Visual Acuity From Baseline to Month 6 and From Baseline to 9 Months Baseline to 9 month	0.02 LogMAR Unit Interval 0.02 to 0.02	-0.12 LogMAR Unit Interval -0.14 to -0.08

SECONDARY outcome

Timeframe: Baseline to 6, 9, and 12 months

A large decrease in CST thickness may be indicative of a worse clinical outcome. These measurements are done to ensure safety of the participants.

Outcome measures

Measure	Observation n=1 Participants Observation; No treatment given	Intravitreal Ranibizumab 2.0mg n=3 Participants Initial dose 2.0mg switched to 1.0mg at near conclusion of study. ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months Baseline to 6 month	-20 Micrometer Interval -20.0 to -20.0	7 Micrometer Interval -2.0 to 20.0
Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months Baseline to 9 month	-16 Micrometer Interval -16.0 to -16.0	-6 Micrometer Interval -17.0 to 12.0
Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months Baseline to 12 month	-11 Micrometer Interval -11.0 to -11.0	-4 Micrometer Interval -14.0 to 2.0

SECONDARY outcome

Timeframe: Baseline to 6 month, baseline to 9 month and baseline to 12 months

Outcome measures

Measure	Observation n=1 Participants Observation; No treatment given	Intravitreal Ranibizumab 2.0mg n=3 Participants Initial dose 2.0mg switched to 1.0mg at near conclusion of study. ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg Baseline to 6 month	0 Number of Adverse Events	0 Number of Adverse Events
Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg Baseline to 9 month	0 Number of Adverse Events	0 Number of Adverse Events
Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg Baseline to 12 month	0 Number of Adverse Events	0 Number of Adverse Events

SECONDARY outcome

Timeframe: Baseline to 6 and baseline to 12 months

Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 6. Also any decreases of angiographic leakage was counted between baseline and 6 month. The same was done between baseline and 12 month.

Any increase of angiographic leakage was counted as a +1. Likewise, any decrease of angiographic leakage was counted as a -1. The sum was calculated based on the number of participants in each arm and the total shown in the outcome. For example: if across the three injected participants for their 6 month visit, two of them showed an increase of angiographic leakage and one showed a decrease, then the outcome would be, (+1) + (+1) + (-1)= +1. Likewise, if the same three participant's 12 month visit showed two with a decrease in leakage and one with no changes in leakage, the outcome would be, (-1) + (-1) + (0)= -2

Outcome measures

Measure	Observation n=1 Participants Observation; No treatment given	Intravitreal Ranibizumab 2.0mg n=3 Participants Initial dose 2.0mg switched to 1.0mg at near conclusion of study. ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
Angiographic Leakage From Baseline to Month 6 and 12 Baseline to 6 month	0 Sum of increases (+1) and decreases (-1)	1 Sum of increases (+1) and decreases (-1)
Angiographic Leakage From Baseline to Month 6 and 12 Baseline to 12 month	0 Sum of increases (+1) and decreases (-1)	-2 Sum of increases (+1) and decreases (-1)

Adverse Events

Observation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Intravitreal Ranibizumab 2.0mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Observation n=3 participants at risk Observation; No treatment given	Intravitreal Ranibizumab 2.0mg n=3 participants at risk Initial dose 2.0mg switched to 1.0mg at near conclusion of study. ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
Endocrine disorders Diabetes	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years
Infections and infestations Ear Infection	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years
Respiratory, thoracic and mediastinal disorders Allergies	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years
Musculoskeletal and connective tissue disorders Stiff Neck	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years
Cardiac disorders Elevated Blood Pressure	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years
Infections and infestations Sinusitis	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years
Immune system disorders Cold	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years
General disorders Food Poisoning	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years

Additional Information

Dr. Arthur Korotkin, MD

Eye Center of Northern Colorado, PC

Phone: 970-221-2222

Email: retina@eyecenternoco.com

Results disclosure agreements

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