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Apellis Derby Study - Geographic Atrophy AMD

Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Study Description:

Condition or Disease

Intervention / Treatment

Phase

Sponsor

Status

Geographic Atrophy

AMD

Drug:  APL-2

Other: Sham

Phase 3

Apellis

Currently Enrolling

This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2  in subjects with GA secondary to AMD.  A will be administered via intravitreal injection in this study. Subjects will receive a single-dose intravitreal injection of APL-2 15mg or sham every month or every other month.  APL-2 is a Complement (C3) Inhibitor.

Eligibility Criteria:

  • Ages Eligible:  60 Years and Older
  • Sexes Eligible:  All

Inclusion Criteria:
Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.

  • Visual acuity (NL-BCVA) of 24 letters or better (approximately 20/320 Snellen equivalent) using ETDRS charts
  • Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center.
  • The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at Screening:
    • Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively).
    • 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.
    • The entire lesion must be completely visualized on the macula centered image. GA must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
    • Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
  • Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
  • Female subjects must be of non-child-bearing potential (WONCBP) agree to use protocol defined methods of contraception for the duration of the study.
  • Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception for the duration of the study.
  • Willing and able to give informed consent and to comply with the study procedures and assessments.

Note: If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the Investigator will determine the study eye.

Exclusion Criteria:
Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.

  • GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
  • Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.
  • Any history or active CNV, associated with AMD or any other cause, including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on SD OCT imaging and/or fluorescein angiography as assessed by the Reading Center.
  • Presence in either eye 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 (e.g. clinically significant epiretinal membrane (ERM), 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).
  • Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
  • History of laser therapy in the macular region.
  • Aphakia or absence of the posterior capsule. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
  • 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.
  • Any contraindication to IVT injection including current ocular or periocular infection.
  • History of prior intravitreal injection in the study eye.
  • Treatment for active systemic or localized infection.
  • Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 24-month treatment period unlikely, or would make the subject an unsafe study candidate.
  • Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution.

Contact:
Beachwood Office - Diane Weiss 216-831-5700    •  
  dew@retina-assoc.com.
Youngstown Office - John Lacombe 330-759-8777    •     jlacombe@retrina-assoc.com.

To learn more: https://gastudy.com/