Combination of Ranibizumab and Targeted Laser Photocoagulation
- Sponsor
- University of Giessen
- Study ID
- NCT04444492
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Central Retinal Vein Occlusion With Macular Edema
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ranibizumab Injection — DRUGinitial three injections of Ranibizumab - afterwards pro re nata monthly
- Laser photocoagulation — DEVICEAreas of capillary non-perfusion will be treated with photocoagulation upto 4 times
Study Details
Intravitreal injections of Ranibizumab will be applied in all patients according to treatment guidelines. The experimental group will receive additional targeted laser photocoagulation of the peripheral areas of capillary non-perfusion (up to 4 laser treatments within 1st year of the study). Based on the long-term observation after CoRaLa I study an importantly shorter duration of treatment and a relevant reduction of the total number of re-injections in RL patients is expected.
Key Dates
- First listed
- Jun 23, 2020
- Start date
- Aug 25, 2020
- Status verified
- May 2026
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 88 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ranibizumab+Laser-armRanibizumab injections and additional targeted laser
- Active Comparator: Ranibizumab-armOnly Ranibizumab injections
Primary Outcome Measure
Efficacy endpoint is the time to treatment success [ Time Frame: up-to 29 months ]