Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO) (COMRADE-C)

Novartis

Status and phase

Completed

Phase 3

Conditions

Macular Edema

Central Retinal Vein Occlusion

Visual Impairment

Treatments

Drug: Dexamethasone implant and sham injections

Drug: Ranibizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01396083

2011-001020-38 (EudraCT Number)

CRFB002EDE18

Details and patient eligibility

About

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.

Enrollment

243 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed with visual impairment due to macular edema following CRVO
Diagnosis of CRVO at maximum 6 months prior to Screening
BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Exclusion criteria

Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
Central retinal thickness (CRT) < 250 µm in the study eye
Prior episode of RVO in the study eye
Active formation of new vessels in the study eye
Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
Improvement of > 10 letters on BCVA between Screening and Baseline

Other protocol-defined inclusion/exclusion criteria may apply