Clinical research study involving an intravitreal injection in the eye with Pegcetacoplan for the treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneratio

Phase 1

• Conditions: Geographic Atrophy Secondary to Age-Related Macular Degeneration; MedDRA version: 20.1Level: LLTClassification code 10063947Term: Geographic atrophySystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-002931-32-NL
• Lead Sponsor: Apellis Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Ocular-specific inclusion criteria apply to the study eye.
1. Participated in APL2-103 (NCT03777332) or completed the treatment at month 24 of
either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600). Specifically, for the APL2-303 and APL2-304 studies, the following criterion also applies:
a. Participants who did not permanently discontinue treatment but missed the month 24 visit are also eligible to participate in this extension study; however, to be eligible, these participants must be screened within 60 days from the last day of the expected month 24 visit window for the antecedent study.
2. Clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the investigator.
3. Female participants must be:
a. Women of nonchildbearing potential, or
b. Women of childbearing potential (WOCBP), defined as any women who have experienced menarche and who are not permanently sterile or postmenopausal, must have a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and 90 days after their last dose of pegcetacoplan, and refrain
from breastfeeding for the duration of the study.
4. Males with female partners of childbearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study and for 90 days after their last dose of pegcetacoplan.
5. Willing and able to give informed consent and to comply with the study procedures and assessments.

Inclusion criterion #2 applies to the fellow eye.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1160

Exclusion Criteria

Ocular-specific exclusion criteria apply to the study eye.
1. Participants who permanently discontinued the study drug prior to month 24 in the APL2-304 or APL2-304 studies and only for safety assessments. Temporary pause of the study drug is not exclusionary.
2. Presence of an active ocular disease that, in the opinion of the investigator, compromises or confounds visual function, including, but not limited to, macular hole or other macular diseases (eg, clinically significant epiretinal membrane). Benign conditions in the opinion
of the investigator such as peripheral retinal dystrophy are not exclusionary.
3. Any contraindication to IVT injection including current ocular or periocular infection.
4. Medical or psychiatric condition that, in the opinion of the investigator, is clinically significant and not suitable for study participation or make consistent follow-up over the 36-month treatment period unlikely.
5. Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to pegcetacoplan or any of the excipients in pegcetacoplan solution.
6. Pregnancy, breastfeeding, or positive pregnancy test.

Exclusion criteria 2 and 3 apply to the fellow eye.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified