A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)
- Sponsor: Apellis Pharmaceuticals, Inc.
- Principal Investigator: Gordon Crabtree, MD
- Study Coordinators: Chris Smith; Meg Hackbarth
Study Objective:
To evaluate the efficacy of multidose APL-3007 and Syfovre/pegcetacoplan (APL-2) on retinal pigment epithelium (RPE) lesion area as assessed by spectral-domain optical coherence tomography (SD-OCT) in patients diagnosed with GA secondary to AMD
Study Design:
Participants will be randomly assigned to receive 1 of 2 doses of APL-3007 dosed in combination with Syfovre/pegcetacoplan (APL2) or subcutaneous placebo dosed with Syfovre/pegcetacoplan (APL-2) in a 1:1:1 ratio.
Inclusion Criteria:
- Aged ≥60 years
- Clinical diagnosis of GA of the macula secondary to AMD in one or both eyes, as determined by the investigator and confirmed by the reading center
- NL-BCVA of 50 letters or better using early treatment diabetic retinopathy study (ETDRS) charts (approximately 20/100 Snellen equivalent)
- Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images in the study eye as determined by the investigator
Exclusion Criteria:
- Uncontrolled, clinically relevant history of any gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, or cancer
- Clinically meaningful abnormalities on diagnostic and laboratory testing and include: Cardiac, Hepatic, Renal
History or presence of malignancy (except history of basal or squamous cell carcinoma of the skin) that has not been successfully treated ≥1 year prior to enrollment - Has poor peripheral venous access or any abnormal skin conditions or potentially obscuring tattoos, pigmentation, or lesions in the area intended for SC injection that would interfere with SC injections or assessments of injection local tolerability
- GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye
- Any history of CNV (active or nonexudative/quiescent) in the study eye associated with AMD or any other cause, including any evidence of RPE rips, double layer sign, or evidence of neovascularization anywhere based on SD-OCT imaging and fluorescein angiography as assessed by the reading center
- Presence of an active ocular disease that, in the opinion of the investigator, compromises or confounds visual function, including but not limited to, uveitis, other macular diseases (eg, clinically significant epiretinal membrane, full thickness macular hole or uncontrolled glaucoma/ocular hypertension); benign conditions in the opinion of the investigator such as peripheral retina dystrophy are not exclusionary.
- History of IVT injection in the study eye within 3 months prior to the screening visit, with the exception of IVT Syfovre
History of laser therapy in the macular region - Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the investigator, could compromise visual function during the study period
Contact Chris Smith at (608) 263-7169 or Meg Hackbarth at (608) 890-4222
For more information about this study, please visit clinicaltrials.gov