A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration - Full Text View

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: 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

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

Secondary Outcome Measures:

Change in Number of Scotomatous Points as Assessed by Mesopic Micrometry [ Time Frame: Baseline to Week 96 ]
Change in Macular Sensitivity as Assessed by Mesopic Microperimetry [ Time Frame: Baseline to Week 96 ]
Change in GA Area as Assessed by FAF [ Time Frame: Baseline to Week 96 ]
Change in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart [ Time Frame: Baseline to Week 96 ]
Change in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions [ Time Frame: Baseline to Week 96 ]
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 ]
Change in Binocular Critical Print Size as Assessed by MNRead Charts or Radner Reading Charts [ Time Frame: Baseline to Week 96 ]
Change in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score [ Time Frame: Baseline to Week 96 ]
Change in NEI VFQ-25 Near Activity Subscale Score [ Time Frame: Baseline to Week 96 ]
Change in NEI VFQ-25 Distance Activity Subscale Score [ Time Frame: Baseline to Week 96 ]
Change in Functional Reading Independence (FRI) Index [ Time Frame: Baseline to Week 96 ]
Percentage of Participants with Ocular Adverse Events [ Time Frame: Baseline up to the end of study (approximately 2 years) ]
Percentage of Participants with Systemic (Non-ocular) Adverse Events [ Time Frame: Baseline up to the end of study (approximately 2 years) ]
Percentage of Participants with Anti-Lampalizumab Antibodies [ Time Frame: Baseline up to the end of study (approximately 2 years) ]
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 ]
Serum Lampalizumab Concentration [ Time Frame: Baseline to Week 96 ]


Enrollment:	905
Actual Study Start Date:	September 17, 2014
Estimated Study Completion Date:	December 31, 2018
Estimated Primary Completion Date:	December 31, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


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

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 145 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:	June 29, 2017


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

ClinicalTrials.gov processed this record on August 22, 2017

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