Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO) (COMRADE-B)

Novartis

Status and phase: Completed; Phase 3

Conditions: Macular Edema; Visual Impairment; Branch Retinal Vein Occlusion

Treatments: Other: Sham injection; Other: Dexamethasone Implant; Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396057

2011-001019-30 (EudraCT Number)

CRFB002EDE17

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 Ranibizumab 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: 244 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with visual impairment due to macular edema following BRVO
• Diagnosis of BRVO 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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244 participants in 2 patient groups

Ranibizumab

Experimental group

Description:

Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally

Treatment:

Drug: Ranibizumab

Dexamethasone

Sham Comparator group

Description:

Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months

Treatment:

Other: Sham injection

Other: Dexamethasone Implant