Trial Outcomes & Findings for Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab (NCT NCT01471691)

NCT ID: NCT01471691

Last Updated: 2015-04-29

Results Overview

Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline to month 6
• Results posted on: 2015-04-29

Participant Flow

Participant milestones

Measure	Intravitreal Ranibizumab 0.5mg ranibizumab 0.5mg: Standard dose Patients were given six months of monthly treatment with the standard 0.5mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.	Intravitreal Ranibizumab 1.0mg ranibizumab 1.0mg: High dose Patients were given six months of monthly treatment with the 1.0mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
Overall Study STARTED	8	6
Overall Study COMPLETED	8	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Intravitreal Ranibizumab 0.5mg ranibizumab 0.5mg: Standard dose Patients were given six months of monthly treatment with the standard 0.5mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.	Intravitreal Ranibizumab 1.0mg ranibizumab 1.0mg: High dose Patients were given six months of monthly treatment with the 1.0mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab

Baseline characteristics by cohort

Measure	Intravitreal Ranibizumab 0.5mg n=8 Participants ranibizumab 0.5mg: Standard dose	Intravitreal Ranibizumab 1.0mg n=6 Participants ranibizumab 1.0mg: High dose	Total n=14 Participants Total of all reporting groups
Age, Continuous	73 years STANDARD_DEVIATION 5.0 • n=5 Participants	78 years STANDARD_DEVIATION 5.0 • n=7 Participants	75 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to month 6

Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.

Outcome measures

Measure	Intravitreal Ranibizumab 0.5mg n=8 Participants ranibizumab 0.5mg: Standard dose	Intravitreal Ranibizumab 1.0mg n=5 Participants ranibizumab 1.0mg: High dose
Mean Change From Baseline BCVA	14 Letters (ETDRS chart) Standard Deviation 10	5 Letters (ETDRS chart) Standard Deviation 6

SECONDARY outcome

Timeframe: months 1-12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 1-12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6 and 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6 and 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: month 12

Outcome measures

Outcome data not reported

Adverse Events

Intravitreal Ranibizumab 0.5mg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravitreal Ranibizumab 1.0mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intravitreal Ranibizumab 0.5mg n=8 participants at risk ranibizumab 0.5mg: Standard dose	Intravitreal Ranibizumab 1.0mg n=6 participants at risk ranibizumab 1.0mg: High dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	12.5% 1/8 • Number of events 1	0.00% 0/6
Ear and labyrinth disorders Ruptured Retinal Macroaneurysm	12.5% 1/8 • Number of events 1	0.00% 0/6

Other adverse events

Adverse event data not reported

Additional Information

Thomas O'Hearn MD

Thomas Hanscom AMC

Phone: 310-829-3303

Email: tohearn@gmail.com

Results disclosure agreements

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