Overview

Combination of Ranibizumab and Targeted Laser Photocoagulation

Status:
Recruiting
Trial end date:
2024-07-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Leipzig
Treatments:
Ranibizumab
Criteria
Inclusion Criteria:

- Diagnosis of macular edema due to central retinal vein occlusion foveal thickness >
250 μm (measured by OCT)

- Age > 18 years

- Written informed consent of the patient

- BCVA score in the study eye between 24 letters (20/320) and 78 letters (20/25)
measured in ETDRS chart

- History of CRVO no longer than 6 months

- Presence of capillary non-perfusion in peripheral retina larger than 5 disc areas
documented in ultra wide-field fluorescein angiography

- Ability and willingness to attend all scheduled visits and assessments

Exclusion Criteria:

- CRVO with ischemic maculopathy defined as diameter of the foveolar avascular zone
larger than 2 optic disc diameters

- Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic
maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)

- History of idiopathic central serous chorioretinopathy

- Presence of vitreoretinal interface disease (e.g. vitreomacular traction, epiretinal
membrane), either on clinical examination or in OCT

- An eye that, in the investigator's opinion, would not benefit from resolution of
macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense
subfoveal hard exudates

- Aphakia in the study eye

- Scatter laser photocoagulation or macular photocoagulation in the study eye prior to
study entry

- Intraocular or periocular injection of steroids in the study eye prior to study entry

- Previous use of an anti-VEGF drug in the study eye

- Cataract surgery or any other intraocular surgery in the study eye within 3 months
prior to study entry

- Uncontrolled glaucoma (defined as intraocular pressure ≥ 30 mm Hg despite treatment
with maximal anti-glaucoma medications)

- History of stroke, myocardial infarction, transient ischemic attacks within 3 months
prior to the study

- Pregnancy (positive urine pregnancy test) or lactation

- The presence of active malignancy, including lymphoproliferative disorders.

- History of allergy to fluorescein or any component of the ranibizumab formulation

- Active intraocular infection

- Participation in another simultaneous interventional medical investigation or trial

- Women with child bearing potency without effective contraception (i. e. implants,
injectables, combined oral contraceptives, some IUDs or vasectomised partner) during
the conduct of the trial.