A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (CHROMA)

Roche

Status and phase: Terminated; Phase 3

Conditions: Geographic Atrophy

Treatments: Other: Sham; Drug: Lampalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02247479

GX29176

2014-000107-27 (EudraCT Number)

Details and patient eligibility

About

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Enrollment: 906 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion criteria

Ocular Exclusion Criteria: Study Eye

• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
• Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
• Previous intravitreal drug delivery (intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria: Both Eyes
• GA in either eye due to causes other than AMD
• Previous treatment with eculizumab, lampalizumab and/or fenretinide

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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906 participants in 3 patient groups

Lampalizumab Once in Every 4 Weeks (Q4W)

Experimental group

Description:

Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.

Treatment:

Drug: Lampalizumab

Lampalizumab Once in Every 6 Weeks (Q6W)

Experimental group

Description:

Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.

Treatment:

Drug: Lampalizumab

Sham Comparator

Sham Comparator group

Description:

Participants will receive sham comparator Q4W or Q6W for 96 weeks.

Treatment:

Other: Sham