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

Roche

Status and phase: Terminated; Phase 3

Conditions: Geographic Atrophy

Treatments: Other: Sham Comparator; Drug: Lampalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02247531

GX29185

2014-000106-35 (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: 975 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants aged greater than or equal to (>/=) 50 years
• 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 (e.g., 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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975 participants in 3 patient groups

Lampalizumab once in every 4 weeks (Q4W)

Experimental group

Description:

Participants will receive 10 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.

Treatment:

Drug: Lampalizumab

Lampalizumab once in every 6 weeks (Q6W)

Experimental group

Description:

Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.

Treatment:

Drug: Lampalizumab

Sham Comparator

Sham Comparator group

Description:

Participants will receive sham comparator, Q4W, starting at the Day 1 visit for approximately 92 weeks or Q6W, starting at the Day 1 visit for approximately 90 weeks.

Treatment:

Other: Sham Comparator