Ranibizumab combined with selective peripheral laser photocoagulation for treatment of central retinal vein occlusio
- Conditions
- H34.8Other retinal vascular occlusions
- Registration Number
- DRKS00000711
- Lead Sponsor
- Klinik und Poliklinik für AugenheilkundeUniversität Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 22
1.Diagnosis of macular edema due to central retinal vein occlusion foveal thickness = 250 µm (measured by OCT)
2.Age = 18 years
3.Written informed consent of the patient
4.BCVA score in the study eye between 24 letters (20/320) and 73 letters (20/40) measured in ETDRS chart
5.The history of CRVO no longer than 8 months
6.Presence of capillary non-perfusion in peripheral retina larger than 1 and smaller than 10 disc areas documented in fluorescein angiography
7.Ability and willingness to attend all scheduled visits and assessments
1.Ischemic CRVO defined as presence of capillary non-perfusion larger than 10 optic disc areas in fluorescein angiography
2.Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
3. Diagnosis of CRVO in both eyes with macular edema requiring any kind of treatment
4.History of rhegmatogenous retinal detachment
5.History of idiopathic central serous chorioretinopathy
6.Presence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or in OCT
7.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
8. Patients in which at time of screening the anti-VEGF treatment is planned for the fellow eye for any reason
9.Aphakia
10.Improvement of > 10 letters on BCVA between screening and Day 1
11.Scatter laser photocoagulation or macular photocoagulation in the study eye prior to study entry
12.Use of intraocular or periocular injection of steroids in the study eye prior to study entry
13.Previous use of an anti-VEGF drug in the study eye
14.Cataract surgery or Yttrium-Aluminum-Garnet (YAG) laser capsulotomy or any other intraocular surgery in the study eye within 3 months prior to study entry
15.History or presence of AMD (dry or wet form)
16.Uncontrolled glaucoma (defined as intraocular pressure = 30 mm Hg despite treatment with anti-glaucoma medications)
17.Uncontrolled blood pressure defined as pressure = 160/90 mmHg in at least 3 consecutive measurements
18.History of cerebral vascular accident
19.Pregnancy (positive pregnancy test) or lactation
20.The presence of active malignancy, including lymphoproliferative disorders.
21.History of allergy to humanized antibodies or any component of the ranibizumab or fluorescein formulation
22.Inability to comply with study procedures
23.Participation in another simultaneous medical investigation or trial
24.Ongoing drug abuse
25.HIV positive
26.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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the best corrected visual acuity (BCVA) from baseline to 6 months (week 24)measured in ETDRS letters
- Secondary Outcome Measures
Name Time Method 1. Change score in central retinal thickness (CRT), assessed by OCT between Week 1 and week 24. <br>2. Number of Ranibizumab injections applied per patients in total between week 1 to week 24.<br>3. Proportion of patients per group progressing to anterior segment neovascularization, neovascularization of the optic disc (NVD), or neovascularization of the retina elsewhere (NVE) requiring pan-retinal photocoagulation.<br>4. Number of adverse events (AEs) and serious adverse events (SAEs) per group