H34.8
Conditions
Interventions
Group 1: Experimental intervention: RL group (Ranibizumab plus laser): Patients randomized to this group receive an intravitreal injection of 0.5 mg ranibizumab with additional selective laser photoco
Sponsors
Klinik und Poliklinik für Augenheilkunde
Universität Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the best corrected visual acuity (BCVA) from baseline to 6 months (week 24)measured in ETDRS letters | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change score in central retinal thickness (CRT), assessed by OCT between Week 1 and week 24. 2. Number of Ranibizumab injections applied per patients in total between week 1 to week 24. 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. 4. Number of adverse events (AEs) and serious adverse events (SAEs) per group | — |
Countries
Germany
Contacts
Public ContactMatus Rehak, Ph.D.
Klinik und Poliklinik für Augenheilkunde Universität Leipzig
Outcome results
None listed