Trial intelligence / Profile preview

STAR: OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab

NCT01243086Phase 2

Key facts

Status: Completed
Start: Mar 2011
Primary completion: May 2015
Countries: 1
Sponsor: McMaster University
Modality: Implantable Devices, Implantable Hydrogels, Small Molecules

Drugs: ozurdex
Conditions: exudative macular degeneration

Overview

Phase 2, randomised, double-blind trial of ozurdex in exudative macular degeneration (2 arms), sponsored by McMaster University. Primary endpoint: Gains in visual acuity at 6 months. Started Mar 2011; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Ranibizumab
Intravitreal injections of ranibizumab (0.5mg/0.05 mL) + placebo injection monthly for up to 6 months.
Ranibizumab and OZURDEX
Intravitreal injections of ranibizumab (0.5mg/0.05 mL) + OZURDEX (0.7mg) monthly for up to 6 months.

Who it enrols

Adults over 18 years old with wet age-related macular degeneration and sub-foveal choroidal neo-vascularization, with visual acuity between 20/40 and 20/320. Patients must not have had prior CNV treatment in the study eye, recent intra-ocular surgery, or medically uncontrolled glaucoma.

Endpoints

Primary

Gains in visual acuity6 months

Secondary

Changes in intraocular pressure6 months
Rates of re-treatment6 months
Rate of vision loss6 months
Rate of cataract progression6 months
Changes in choroid vessel activity in lesion growth and activity at choroid6 months

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