ong-term need of the drug ranibizumab applied as injection into the eye with or without early targeted peripheral laser photocoagulation of the retina for treatment of macular edema due to central retinal vein occlusio

Phase 1

• Conditions: Macular edema due to central retinal vein occlusion; MedDRA version: 20.0Level: LLTClassification code 10054467Term: Macular edemaSystem Organ Class: 100000004853; MedDRA version: 20.0Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-000681-42-DE
• Lead Sponsor: Justus-Liebig University Gießen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-29
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1.Diagnosis of macular edema due to central retinal vein occlusion foveal thickness >250 µm (measured by optical coherence tomography (OCT))
2.Age ? 18 years
3.Written informed consent of the patient
4.Best corrected visual acuity (BCVA) score in the study eye between 24 letters (20/320) and 78 letters (20/25) measured in ETDRS chart
5.History of central retinal vein occlusion (CRVO) no longer than 6 months
6.Presence of capillary non-perfusion in peripheral retina larger than 5 disc areas documented in ultra wide-field 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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

1. CRVO with ischemic maculopathy defined as diameter of the foveolar avascular zone larger than 2 optic disc diameters
2.Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
3.History of idiopathic central serous chorioretinopathy
4.Presence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or in OCT
5.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
6.Aphakia in the study eye
7.Scatter laser photocoagulation or macular photocoagulation in the study eye prior to study entry
8.Intraocular or periocular injection of steroids in the study eye prior to study entry
9.Previous use of an anti-VEGF drug in the study eye
10.Cataract surgery or any other intraocular surgery in the study eye within 3 months prior to study entry
11.Uncontrolled glaucoma (defined as intraocular pressure = 30 mmHg despite treatment with maximal anti-glaucoma medications)
12.History of stroke, myocardial infarction, transient ischemic attacks within 3 months prior to the study
13.Pregnancy (positive urine pregnancy test) or lactation
14.The presence of active malignancy, including lymphoproliferative disorders.
15. History of allergy to fluorescein or a component of the ranibizumab formulation
16.Active intraocular infection
17.Participation in another simultaneous interventional medical investigation or trial
18.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