Overview

Pegcetacoplan (APL-2) in Neovascular AMD

Status:
Terminated
Trial end date:
2019-04-05
Target enrollment:
0
Participant gender:
All
Summary
Safety Assessment of Pegcetacoplan in Patients with Neovascular AMD
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Apellis Pharmaceuticals, Inc.
Criteria
Inclusion Criteria:

1. Age greater than or equal to 60 years.

2. Normal Luminance best corrected visual acuity (NL-BCVA) of 24 letters or better using
Early Treatment Diabetic Retinopathy Study (ETDRS) charts (20/320 Snellen equivalent).

3. Clinical diagnosis of neovascular AMD with the following criteria met:

1. Eligible for an injection of an anti-VEGF injection with macular fluid present at
Day -28.

2. Must have been treated with anti-VEGF in study eye for at least 6 months prior to
joining the study.

3. At least 6 months of intravitreal anti-VEGF therapy at intervals not greater than
8 weeks (± 7 days) for the past 2 injections in the eye that is selected to be
the study eye.

4. A clinically meaningful (50%) reduction in excess macular fluid or macular thickness
in the study eye at the discretion of the investigator between Screening Day -28 and
Screening Day -14 as assessed by SD-OCT.

5. Female subjects must be:

1. Women of non-child-bearing potential (WONCBP), or

2. Women of child-bearing potential (WOCBP) with a negative 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.

6. 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.

7. Willing and able to give informed consent and to comply with the study procedures and
assessments

Exclusion Criteria:

1. Presence of other causes of choroidal neovascularization (CNV) including pathologic
myopia (spherical equivalent ≥ -6 diopters), central serous chorioretinopathy, ocular
histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal
choroiditis.

2. History of vitrectomy to the study eye

3. Presence of any ophthalmologic condition that reduces the clarity of the media and
that, in the opinion of the Investigator, interferes with ophthalmologic examination
(e.g. advanced cataract or corneal abnormalities).

4. Intraocular surgery (including lens replacement surgery) within 3 months prior to
randomization.

5. Any history of endophthalmitis.

6. Trabeculectomy or aqueous shunt or valve in the study eye.

7. Aphakia or absence of the posterior capsule. Note: previous violation of the posterior
capsule is also excluded unless it occurred as a result of yttrium aluminum garnet
(YAG) laser posterior capsulotomy in association with prior posterior chamber
intraocular lens implantation and at least 60 days prior to baseline.

8. Any ophthalmic condition 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 (e.g. severe uncontrolled glaucoma, clinically significant
diabetic macular edema, ischemic optic neuropathy, retinal vasculopathies).

9. Any contraindication to IVT injection including current ocular or periocular
infection.

10. Current treatment for active systemic or localized infection.

11. Participation in any systemic experimental treatment or any other systemic
investigational new drug within 6 weeks or 5 half-lives of the active (whichever is
longer) prior to the start of study treatment. Note: clinical trials solely involving
observation, over-the-counter vitamins, supplements, or diets are not exclusionary

12. 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.

13. Any baseline laboratory value (hematology, serum chemistry or urinalysis) that in the
opinion of the Investigator is clinically significant and not suitable for study
participation.

14. Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to
pegcetacoplan or any of the excipients in pegcetacoplan solution