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Observation for Macular Degeneration
N/A
Recruiting
Research Sponsored by Apellis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration
Eligible Conditions
- Macular Degeneration
- Age-Related Macular Degeneration
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2020 Phase 3 trial • 80 Patients • NCT0350054941%
Injection site erythema
15%
Injection site pruritus
13%
Headache
13%
Injection site swelling
13%
Diarrhoea
10%
Injection site reaction
9%
Nausea
8%
Pyrexia
8%
Injection site pain
6%
Fatigue
6%
Injection site induration
5%
Dyspnoea
5%
Nasopharyngitis
4%
Contusion
4%
Dizziness
4%
Chromaturia
4%
Vaccination site pain
4%
Pain in extremity
4%
Back pain
4%
Myalgia
3%
Vaccination complication
3%
Anxiety
3%
Thrombocytopenia
3%
Cough
3%
Abdominal pain
3%
Abdominal discomfort
3%
Arthralgia
3%
Injection site bruising
3%
Sepsis
1%
Oral herpes
1%
Sinusitis
1%
Haemolysis
1%
Vomiting
1%
Anaemia
1%
Asthenia
1%
Palpitations
1%
Abdominal distension
1%
Constipation
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Run-in Period: Pegcetacoplan + Eculizumab
Open-label Period: Pegcetacoplan
RCP: Eculizumab
RCP: Pegcetacoplan
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ObservationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegcetacoplan
2015
Completed Phase 3
~400
Find a Location
Who is running the clinical trial?
Apellis Pharmaceuticals, Inc.Lead Sponsor
25 Previous Clinical Trials
3,980 Total Patients Enrolled
6 Trials studying Macular Degeneration
2,538 Patients Enrolled for Macular Degeneration
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