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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)

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ClinicalTrials.gov Identifier: NCT02247479
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Resource links provided by the National Library of Medicine


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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247479


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 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