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Observation for Age-Related 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 36 months
Awards & highlights

Study 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
  • Age-Related Macular Degeneration

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of ocular AEs in treated eyes overall and according to physician-directed treatment interval based on US prescribing information
Incidence of other events of interest
Secondary outcome measures
Assess real-world treatment patterns and use of pegcetacoplan considering the proportion of participants with bilateral GA treated with pegcetacoplan in both eyes
If only one eye is treated, the criteria for determination of the eye to be treated
The duration of persistence on treatment: continuous medication usage until a gap of ≥3 months
+8 more

Side effects data

From 2020 Phase 3 trial • 80 Patients • NCT03500549
17%
Haemolysis
16%
Nasopharyngitis
14%
Diarrhoea
12%
Injection site erythema
12%
Cough
10%
Headache
10%
Fatigue
9%
Urinary tract infection
9%
Upper respiratory tract infection
8%
Oral herpes
8%
Pyrexia
8%
Oropharyngeal pain
8%
Arthralgia
6%
Injection site induration
6%
Injection site pruritus
6%
Pain in extremity
5%
Myalgia
5%
Asthenia
5%
Injection site pain
5%
Anxiety
5%
Abdominal distension
5%
Acute kidney injury
5%
Contusion
4%
Dizziness
4%
Vomiting
4%
Hyperbilirubinaemia
4%
Injection site bruising
4%
Hypertension
4%
Thrombocytopenia
4%
Abdominal pain
4%
Erythema
4%
Sinusitis
3%
Chromaturia
3%
Injection site reaction
3%
Nausea
3%
Gastroenteritis
3%
Vaccination complication
3%
Anaemia
3%
Dyspnoea
3%
Constipation
3%
Back pain
3%
Decreased appetite
1%
Injection site swelling
1%
Intestinal ischaemia
1%
Allergy to immunoglobulin therapy
1%
Haemolytic anaemia
1%
Cholelithiasis
1%
Haematoma muscle
1%
COVID-19
1%
Insomnia
1%
Haemoglobinuria
1%
Cytopenia
1%
Small intestinal obstruction
1%
Epistaxis
1%
Ovarian cyst
1%
Hypersensitivity pneumonitis
1%
Oedematous pancreatitis
1%
Biliary sepsis
1%
Diverticulitis
1%
Post procedural sepsis
1%
Sepsis
1%
Palpitations
1%
Diffuse large B-cell lymphoma
1%
Deep vein thrombosis
1%
Acute myeloid leukaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Period: Pegcetacoplan
Run-in Period: Pegcetacoplan + Eculizumab
RCP: Eculizumab
RCP: Pegcetacoplan

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
~380

Find a Location

Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor
24 Previous Clinical Trials
3,725 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06161584.
All > Paid Studies Atlanta > Knoxville
~200 spots leftby Oct 2027
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