Pegcetacoplan for Age-Related Macular Degeneration
(GALE Trial)
Recruiting at 174 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Apellis Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
This trial is testing a medication called pegcetacoplan to see if it is safe and effective for people with a severe eye condition called geographic atrophy, which is related to age-related macular degeneration. The medication aims to protect the eye by blocking harmful immune responses. Pegcetacoplan has shown an acceptable safety profile in previous studies for geographic atrophy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is pegcetacoplan safe for humans?
How is the drug pegcetacoplan unique for treating age-related macular degeneration?
Pegcetacoplan is unique because it targets the complement system, specifically inhibiting a part called complement component 3 (C3), to slow the progression of geographic atrophy, a late stage of age-related macular degeneration. This approach is novel as there are currently no approved treatments for this condition, and pegcetacoplan is the first drug to receive FDA approval for this purpose.34678
Eligibility Criteria
This trial is for people with a specific eye condition called geographic atrophy due to age-related macular degeneration, who were in previous related studies. They must have clear eyes for imaging and agree to birth control measures if applicable. Excluded are those with other significant eye diseases, current pregnancy or breastfeeding, known allergies to study substances, or conditions preventing study participation.Inclusion Criteria
For subjects who participated in either the 303 or 304 studies, the condition listed below must also be met for participating in this study.
I am a woman.
Women who can have children must have a negative result of a blood pregnancy test on the first day of the study visit and agree to use ways to avoid pregnancy during the study and 90 days after the last dose of the study medication.
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Exclusion Criteria
My eye does not have any disqualifying conditions for the study.
If, according to your doctor, any current disease that could directly interfere in your participation in the study or that could make it difficult for you to come to the scheduled visits during the next three years over the next 36 months.
If you currently are pregnant, breastfeed or have a positive pregnancy test.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive intravitreal pegcetacoplan (15 mg/100 μL) monthly or every other month for up to 36 months
36 months
Monthly or every other month visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension
Participants continue to receive treatment to evaluate long-term safety and efficacy
Long-term
Treatment Details
Interventions
- Pegcetacoplan (APL-2)
Trial OverviewThe long-term safety and effectiveness of Pegcetacoplan (APL-2) are being tested in this phase 3 extension study on individuals with geographic atrophy secondary to AMD who participated in earlier related trials.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 monthsExperimental Treatment1 Intervention
Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered monthly intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or monthly sham will receive IVT pegcetacoplan (15 mg/100 μL) monthly for up to approximately 36 months.
Group II: Pegcetacoplan, 15 mg/100 μL, every other month (EOM) for up to 36 monthsExperimental Treatment1 Intervention
Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered every other month (EOM) intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or EOM sham will receive IVT pegcetacoplan (15 mg/100 μL) EOM for up to approximately 36 months.
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Who Is Running the Clinical Trial?
Apellis Pharmaceuticals, Inc.
Lead Sponsor
Trials
26
Recruited
4,300+
Findings from Research
In a study of 75 Japanese patients with neovascular age-related macular degeneration (AMD), pegaptanib sodium as maintenance therapy showed stable visual acuity over 54 weeks after successful induction therapy, with no significant changes in vision during this period.
The treatment was well-tolerated, with only 5.3% of patients reporting adverse events, and mean intraocular pressure remained stable, indicating a favorable safety profile for pegaptanib maintenance therapy.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Maintenance therapy with pegaptanib sodium for neovascular age-related macular degeneration: an exploratory study in Japanese patients (LEVEL-J study).Ishibashi, T.[2022]
Abicipar pegol showed comparable efficacy in improving visual acuity and reducing retinal thickness in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) in both Japan and the United States, with mean visual acuity changes of +7.8 to +8.9 letters in Japan and +4.4 to +10.1 letters in the U.S. after 16 weeks.
The treatment was generally safe, with only three cases of uveitis or vitritis reported among abicipar-treated patients, indicating a favorable safety profile for this medication.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Patients With Neovascular Age-Related Macular Degeneration: Studies in Japan and the United States.Kunimoto, D., Ohji, M., Maturi, RK., et al.[2019]
In a study of 253 patients with neovascular age-related macular degeneration (NV-AMD) treated with pegaptanib sodium, over 90% of patients experienced less than 15 letters of vision loss after 24 and 54 weeks, which is significantly better than the 70% reported in the VISION trial.
Pegaptanib was well tolerated among patients, with no serious adverse effects such as endophthalmitis or retinal detachment reported, indicating a favorable safety profile for this treatment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Intravitreal pegaptanib sodium for choroidal neovascularisation secondary to age-related macular degeneration: Pan-European experience.Sivaprasad, S., Hykin, P., Saeed, A., et al.[2016]
References
Maintenance therapy with pegaptanib sodium for neovascular age-related macular degeneration: an exploratory study in Japanese patients (LEVEL-J study). [2022]
Pegaptanib sodium for neovascular age-related macular degeneration: third-year safety results of the VEGF Inhibition Study in Ocular Neovascularisation (VISION) trial. [2022]
Pegcetacoplan treatment for geographic atrophy due to age-related macular degeneration: a plain language summary of the FILLY study. [2022]
The complement system: a novel therapeutic target for age-related macular degeneration. [2023]
Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Patients With Neovascular Age-Related Macular Degeneration: Studies in Japan and the United States. [2019]
Presumed Silicone Oil Droplets After Intravitreal Pegcetacoplan Injections. [2023]
Intravitreal pegaptanib sodium for choroidal neovascularisation secondary to age-related macular degeneration: Pan-European experience. [2016]
Treatment of geographic atrophy: an update on data related to pegcetacoplan. [2023]
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