Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy

Part of paid clinical trials in Bakersfield, California.

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT03777332
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Safety Assessment of APL-2 in Patients with Geographic Atrophy

Key Dates

Start date
Nov 5, 2018
Status verified
Nov 2021
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021

Study Design

Enrollment
19 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: (Cohort 1) Pegcetacoplan, 15 mg/100 μL, monthly for up to 60 months
  • Experimental: (Cohort 2) Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 months
  • Experimental: (Cohort 2) Pegcetacoplan, 15 mg/100 μL, every other month for up to 36 months

Primary Outcome Measure

Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 25 Months ]

Locations (5)

FacilityCityStateZIPSite coordinators
California Retina ConsultantsBakersfieldCalifornia93309-
Retina Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
The Retina PartnersEncinoCalifornia91436-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Retina Consultants of HoustonThe WoodlandsTexas77384-

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