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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Geographic Atrophy	Drug: Lampalizumab; Other: Sham	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	906 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Actual Study Start Date :	September 18, 2014
Actual Primary Completion Date :	January 29, 2018
Actual Study Completion Date :	January 29, 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Lampalizumab Once in Every Weeks (Q4W); Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.	Drug: Lampalizumab; Participants will receive 10 mg dose of lampalizumab administered intravitreally.; Other Name: RO5490249
Experimental: Lampalizumab Once in Every 6 Weeks (Q6W); Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.	Drug: Lampalizumab; Participants will receive 10 mg dose of lampalizumab administered intravitreally.; Other Name: RO5490249
Sham Comparator: Sham Comparator; Participants will receive sham comparator Q4W or Q6W for 96 weeks.	Other: Sham; A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.

Outcome Measures

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Primary Outcome Measures :

1. Change from Baseline in GA Area, as Assessed by Fundus Autofluoresence (FAF) at Year 1 [ Time Frame: Baseline, Year 1 ]

Secondary Outcome Measures :

1. Change in Number of Scotomatous Points as Assessed by Mesopic Micrometry [ Time Frame: Baseline to Week 96 ]
2. Change in Macular Sensitivity as Assessed by Mesopic Microperimetry [ Time Frame: Baseline to Week 96 ]
3. Change in GA Area as Assessed by FAF [ Time Frame: Baseline to Week 96 ]
4. Change in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart [ Time Frame: Baseline to Week 96 ]
5. Change in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions [ Time Frame: Baseline to Week 96 ]
6. Change in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts [ Time Frame: Baseline to Week 96 ]
7. Change in Binocular Critical Print Size as Assessed by MNRead Charts or Radner Reading Charts [ Time Frame: Baseline to Week 96 ]
8. Change in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score [ Time Frame: Baseline to Week 96 ]
9. Change in NEI VFQ-25 Near Activity Subscale Score [ Time Frame: Baseline to Week 96 ]
10. Change in NEI VFQ-25 Distance Activity Subscale Score [ Time Frame: Baseline to Week 96 ]
11. Change in Functional Reading Independence (FRI) Index [ Time Frame: Baseline to Week 96 ]
12. Percentage of Participants with Ocular Adverse Events [ Time Frame: Baseline up to the end of study (approximately 2 years) ]
13. Percentage of Participants with Systemic (Non-ocular) Adverse Events [ Time Frame: Baseline up to the end of study (approximately 2 years) ]
14. Percentage of Participants with Anti-Lampalizumab Antibodies [ Time Frame: Baseline up to the end of study (approximately 2 years) ]
15. Prognostic Value of the Complement Factor I (CFI) Profile Biomarker Based on the Biomarker Status at Baseline and Change in the GA Area from Baseline as Measured by FAF at Year 1 [ Time Frame: Baseline, Year 1 ]
16. Serum Lampalizumab Concentration [ Time Frame: Baseline to Week 96 ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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 (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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 145 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT02247479 History of Changes
Other Study ID Numbers:	GX29176; 2014-000107-27 ( EudraCT Number )
First Posted:	September 25, 2014
Last Update Posted:	April 18, 2018
Last Verified:	April 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

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