Geographic Atrophy
Conditions
Brief summary
Safety Assessment of APL-2 in Patients with Geographic Atrophy
Interventions
Complement (C3) Inhibitor
Sponsors
Apellis Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort 1 The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the worst normal luminance best-corrected visual acuity (NL-BCVA) at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the eye with the larger GA lesion will be selected as the study eye. If both eyes have the same GA lesion size, the right eye will be selected as the study eye. Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified. 1. Age ≥ 60 years. 2. Normal Luminance best corrected visual acuity of between 35 and 5 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately between 20/200 and 20/800 Snellen equivalent). 3. Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center. 4. The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening: 1. Total GA area must be ≥ 2.5 (1 disk areas \[DA\]). 2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 4a. 5. Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator. 6. Female subjects must be: 1. Women of non-child-bearing potential (WONCBP), or 2. Women of child-bearing potential (WOCBP) with a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study. 7. Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study. 8. Willing and able to give informed consent and to comply with the study procedures and assessments.
Exclusion criteria
Cohort 1 Ocular specific
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs) | 25 Months |
Countries
United States
Outcome results
None listed