Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD

NCT ID: NCT02461771

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-28
• Study Completion Date: 2016-03-08

Brief Summary

The objective of this study is to provide initial safety, tolerability and pharmacokinetics information of intravitreal administration of pegcetacoplan in order to support further development into larger Phase II studies for treatment of patients with AMD.

Conditions

Neovascular Age-Related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegcetacoplan Cohort 1

4 mg of pegcetacoplan 100 μL IVT injection

Group Type: EXPERIMENTAL

Pegcetacoplan

Intervention Type: DRUG

On treatment day, subjects will be administered a single 100 μL IVT injection of pegcetacoplan at the dose corresponding to their treatment assignment.

Pegcetacoplan Cohort 2

10 mg of pegcetacoplan 100 μL IVT injection

Group Type: EXPERIMENTAL

Pegcetacoplan

Intervention Type: DRUG

On treatment day, subjects will be administered a single 100 μL IVT injection of pegcetacoplan at the dose corresponding to their treatment assignment.

Pegcetacoplan Cohort 3

20 mg of pegcetacoplan 100 μL IVT injection

Group Type: EXPERIMENTAL

Pegcetacoplan

Intervention Type: DRUG

On treatment day, subjects will be administered a single 100 μL IVT injection of pegcetacoplan at the dose corresponding to their treatment assignment.

Interventions

Pegcetacoplan

On treatment day, subjects will be administered a single 100 μL IVT injection of pegcetacoplan at the dose corresponding to their treatment assignment.

Intervention Type: DRUG

Other Intervention Names

APL-2

Eligibility Criteria

Inclusion Criteria

1. Male or Female

2. Age ≥ 50 years

3. The presence of an active choroidal neovascular lesion secondary to AMD

4. On treatment with anti-VEGF therapy (Lucentis®, Eylea® or Avastin®)

5. Must have received at least 3 anti-VEGF treatments over the 26-week period prior to screening (Screening Visit)

6. Evidence that the macular fluid has responded to anti-VEGF in the past based on OCT in the opinion of PI

7. At screening, evidence of subretinal fluid and retinal cystic changes

8. Must have received anti-VEGF treatment within 10 days prior to pegcetacoplan treatment (anti-VEGF can be administered on the same day of the screening visit after the screening procedures have been completed)

9. OCTs of sufficient quality to allow for the assessment of the central macular fluid can be obtained

10. Female subjects must be:

• Women of non-child-bearing potential (WONCBP), Or
• 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

11. 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

12. Willing and able to give informed consent

Exclusion Criteria

1. Choroidal neovascularization associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc

2. Decreased vision due to retinal disease not attributable to choroidal neovascularization, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy

3. Additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy

4. Decreased vision due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina

5. Cataract surgery within three months of enrollment

6. Presence of any hemorrhage

7. History of treatment for CNV:

1. Previous PDT treatment within 30 days prior to enrollment in the study

2. Previous extrafoveal or juxtafoveal thermal laser photocoagulation within 30 days prior to enrollment in the study

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

9. Medical problems that make consistent follow-up over the treatment period unlikely (e.g. stroke, severe MI, end stage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections

10. Hypersensitivity to fluorescein

• Minimum Eligible Age: 50 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

United States, California

Beverly Hills, California, United States

United States, Florida

Miami, Florida, United States

United States, New Hampshire

Portsmouth, New Hampshire, United States

Australia, New South Wells

Parramatta, New South Wales, Australia

Countries

United States; Australia

Other Identifiers

POT-CP043014

Identifier Type: -

Identifier Source: org_study_id