Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
Conditions
Keywords
GA secondary to AMD
Brief summary
This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead). The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) are in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Interventions
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol 2. Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol 3. BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol 4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol 5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol Key
Exclusion criteria
1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy 2. History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol 3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization 4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization 5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study 6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol Systemic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF) | To week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Loss of Best Corrected Visual Acuity (BCVA) ≥15 letters [Early Treatment Diabetic Retinopathy Study (ETDRS)] from baseline | At week 52 and week 104 |
| Change from baseline in Low-Contrast quantitative Visual Acuity (LC-qVA) | At week 52 and week 104 |
| Change from baseline in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA) | At week 52 and week 104 |
| Change from baseline in quantitative Contrast Sensitivity Function (qCSF) | At week 52 and week 104 |
| Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline measured by FAF | To week 104 |
| Concentrations of total pozelimab in serum | Through week 52 and through week 104 |
| Concentrations of total cemdisiran in plasma | Through week 52 and through week 104 |
| Change from baseline in concentration of total Complement component 5 (C5) | Through week 52 and through week 104 |
| Incidence of Antidrug antibody (ADA) to pozelimab | Through week 52 and through week 104 |
| Magnitude of ADA to pozelimab | Through week 52 and through week 104 |
| Incidence of ADA to cemdisiran | Through week 52 and through week 104 |
| Magnitude of ADA to cemdisiran | Through week 52 and through week 104 |
| Incidence of Neutralizing Antibody (NAb) to pozelimab | Through week 52 and through week 104 |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Through week 52, 104, 140 and week 296 |
| Severity of TEAEs | Through week 52, 104, 140 and week 296 |
Countries
Austria, Canada, France, Germany, Hungary, Italy, Poland, Spain, United Kingdom, United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed