The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of pegcetacoplan in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).
This is a Phase II, prospective, multicenter, randomized, single-masked, sham-controlled study to assess the safety, tolerability and evidence of activity of multiple IVT injections of pegcetacoplan in subjects with GA secondary to Age-Related Macular Degeneration. The study will randomize approximately 240 subjects to obtain at least 200 evaluable subjects across 40 multinational sites. Subjects will be randomized in a 2:2:1:1 manner to receive pegcetacoplan Monthly (AM), pegcetacoplan Every-Other-Month (AEOM), Sham injection Monthly (SM) or Sham injection Every-Other-Month (SEOM), respectively. All subjects will return to the clinical site on Day 7 to assess acute safety after the first injection. After that, subjects in the monthly groups will return to the clinical site for additional pegcetacoplan (or Sham) injections and study procedures every month until Month 12. Subjects in the Every-Other-Month groups will return to the clinical site for additional pegcetacoplan (or Sham) injections and study procedures every two months until Month 12. All subjects will return for follow-up visits on Months 15 and 18 (3 and 6 months after last injection, respectively).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
246
Least Square (LS) Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12
The square root GA lesion size (i.e. transformed area of GA) was measured by FAF photographs. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time frame: Baseline (screening) and Month 12.
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) in the Study Eye, Including by Severity
A TEAE was defined as any adverse event (AE) that commenced or worsened on or after time of first study drug administration up to 60 days beyond last dose of study drug. A treatment-related TEAE was defined as a TEAE with a relationship to study drug of possibly related or probably related or not reported. Severity of TEAEs were categorized as mild; moderate; severe; life-threatening or death related to TEAE, according to Common Terminology Criteria for AEs v4.03. A TEAE of special interest (TEAESI) was defined as a TEAE of scientific and medical concern specific to pegcetacoplan, whether serious or non-serious.
Time frame: From the time of first study drug administration (Day 1) up to Month 12 (Data cut-off date).
LS Mean Change From Baseline in Untransformed GA Lesion Size in the Study Eye at Month 12
The untransformed area of GA was measured by FAF. Baseline is defined as the last available, non-missing observation prior to first study drug administration.
Time frame: Baseline (Day 1) and Month 12.
LS Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score of the Study Eye at Month 12
The BCVA letter score was determined using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. The score ranges from 0 to 100 letters, lower number indicating reduced visual acuity; a positive value of change from baseline indicates visual acuity gain and a negative value indicates visual acuity loss.
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Retina Speciality Institute
Mobile, Alabama, United States
Retinal Research Institute
Phoenix, Arizona, United States
Retina Vitreous Asociates Mdical Goup
Beverly Hills, California, United States
The Gavin Herbert Eye Institute/UC Irvine
Irvine, California, United States
University of Southern California - USC Eye Institute
Los Angeles, California, United States
Byers Eye Institute at Stanford, Stanford School of Medicine
Palo Alto, California, United States
New England Retina Associates
New London, Connecticut, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, United States
Retina Health Center
Fort Myers, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
...and 36 more locations
Time frame: Baseline (Day 1) and Month 12.
LS Mean Change From Baseline in Low Luminance BCVA (LL-BCVA) Score in the Study Eye at Month 12
The LL-BCVA was measured by placing a 2.0-log-unit neutral density filter over the best correction and having the participant read the normally illuminated ETDRS chart. The score ranges from 0 to 100 letters, lower number indicating worse vision; a positive value of change from baseline indicates visual acuity gain and a negative value indicates visual acuity loss.
Time frame: Baseline (Day 1) and Month 12.
LS Mean Change From Baseline in Low Luminance VA (LL-VA) Deficit Score in the Study Eye at Month 12
The LL-VA deficit score is calculated as BCVA score minus LL-BCVA score. The LL-VA deficit score ranges from 0 to 100 letters, lower number indicating worse deficit.
Time frame: Baseline (Day 1) and Month 12.
LS Mean Change From Baseline in Distance of GA Lesion From the Fovea (Foveal Encroachment) in the Study Eye at Month 12
The foveal encroachment in the study eye was measured by FAF. Baseline is defined as the last available, non-missing observation prior to first study drug administration.
Time frame: Baseline (Day 1) and Month 12.
Number of Subjects With Any Macular Neovascularization (MNV) TEAEs in the Study Eye
The number of subjects with any MNV TEAEs in the study eye was identified via clinical review of all ocular TEAEs.
Time frame: From the time of first study drug administration (Day 1) up to Month 12 (Data cut-off date).