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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.
See Contacts and Locations
Verified November 2016 by Hoffmann-La Roche
Sponsor:
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
  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:


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

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