Ranibizumab combined with selective peripheral laser photocoagulation for treatment of central retinal vein occlusionA randomized, controlled interventional phase 2b (proof of concept) study of of the efficacy, safety, and tolerability of repeated intravitreal administration of ranibizumab combined with selective laser photocoagulation of non-perfused retinal areas in subjects with macular edema secondary to central retinal vein occlusion (CRVO)

Phase 1

• Conditions: macular edema secondary to non-ischemic central retinal vein occlusion; MedDRA version: 14.0Level: LLTClassification code 10054467Term: Macular edemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.0Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-020441-27-DE
• Lead Sponsor: niversity of Leipzig Ritterstr. 26, 04109 Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-23
• Study Completion: 2012-09-18
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

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 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 clinical trial of medicinal product
• Study Design: Not specified