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Trial record 1 of 2 for:
gx29176
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (CHROMA)
This study is currently recruiting participants.
Verified November 2016 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02247479
First received: July 15, 2014
Last updated: November 1, 2016
Last verified: November 2016
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Geographic Atrophy | Drug: Lampalizumab Other: Sham | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Change in GA area, as assessed by retinal imaging [ Time Frame: From baseline to Week 48 ]
Secondary Outcome Measures:
- Mean change from baseline in BCVA at 2 years as assessed by ETDRS chart under low luminance conditions at a starting distance of 4 meter (m) [ Time Frame: From baseline to 2 years ]
- Mean change from baseline in BCVA over time as assessed by ETDRS chart under low luminance conditions at a starting distance of 4 m [ Time Frame: from baseline to 2 years ]
- Mean change from baseline in mean binocular reading speed at 2 years as assessed by MNRead charts or Radner Reading Charts [ Time Frame: From baseline to Week 48 ]
- Mean change from baseline in FRI Index score at 2 years [ Time Frame: From baseline to 2 years ]
| Estimated Enrollment: | 936 |
| Study Start Date: | September 2014 |
| Estimated Study Completion Date: | September 2018 |
| Estimated Primary Completion Date: | September 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Q4W Lampalizumab |
Drug: Lampalizumab
10-mg dose of lampalizumab administered intravitrally
Other Name: RO5490249
|
| Experimental: Q6W Lampalizumab |
Drug: Lampalizumab
10-mg dose of lampalizumab administered intravitrally
Other Name: RO5490249
|
| Sham Comparator: Sham |
Other: Sham
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab
|
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants aged >/= 50 years
- Well demarcated area(s) of GA secondary to 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02247479
Show 144 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02247479
Contacts
| Contact: Reference Study ID Number: GX29176 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. and Canada) | global.rochegenentechtrials@roche.com |
Show 144 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT02247479 History of Changes |
| Other Study ID Numbers: |
GX29176 2014-000107-27 ( EudraCT Number ) |
| Study First Received: | July 15, 2014 |
| Last Updated: | November 1, 2016 |
Additional relevant MeSH terms:
|
Macular Degeneration Atrophy Geographic Atrophy Retinal Degeneration Retinal Diseases |
Eye Diseases Pathological Conditions, Anatomical Immunoglobulin Fab Fragments Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017