Pegcetacoplan (APL-2) in Neovascular AMD

NCT ID: NCT03465709

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2019-04-05

Brief Summary

Safety Assessment of Pegcetacoplan in Patients with Neovascular AMD

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegcetacoplan Study Drug

Group Type: EXPERIMENTAL

Pegcetacoplan

Intervention Type: DRUG

Study Drug

Interventions

Pegcetacoplan

Study Drug

Intervention Type: DRUG

Other Intervention Names

APL-2

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apellis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Federico Grossi, MD, PhD

Role: STUDY_DIRECTOR

Apellis Pharmaceuticals, Inc.

Locations

Apellis Clinical Site

Beverly Hills, California, United States

Apellis Clinical Site

Hagerstown, Maryland, United States

Apellis Clinical Site

Cleveland, Ohio, United States

Apellis Clinical Site

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

APL2-203

Identifier Type: -

Identifier Source: org_study_id