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Complement Inhibitor

APL-2 for Age-Related Macular Degeneration

Phase 3
Waitlist Available
Research Sponsored by Apellis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be selected as the study eye.
Age ≥ 60 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (screening) and month 24
Awards & highlights

Study Summary

This trial will assess whether a treatment for age-related macular degeneration is effective and safe.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The study eye must be affected by a disease that is restricted to the eye.
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The best corrected visual acuity is at least 20/24 (6/6.
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The GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
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The criteria for the examination of the cornea and anterior segment of the eye must be met.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (screening) and month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (screening) and month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12
Secondary outcome measures
LS Mean Change From Baseline in Mean Functional Reading Independence (FRI) Index Score at Month 24
LS Mean Change From Baseline in Monocular Maximum Reading Speed of the Study Eye at Month 24
LS Mean Change From Baseline in Normal-Luminance Best-Corrected Visual Acuity (NL-BCVA) Score of the Study Eye at Month 24
+2 more

Side effects data

From 2021 Phase 3 trial • 53 Patients • NCT04085601
13%
Pain in extremity
13%
Hypokalaemia
11%
Arthralgia
11%
Dizziness
9%
Pyrexia
9%
Headache
7%
Thrombocytopenia
7%
Ecchymosis
7%
Erythema
7%
Viral infection
7%
Anaemia
7%
Haemolysis
7%
Musculoskeletal pain
7%
Abdominal pain
7%
Abdominal pain upper
7%
Cough
7%
Epistaxis
7%
Somnolence
7%
Blood creatinine increased
2%
Rhinitis allergic
2%
Febrile neutropenia
2%
Neutropenia
2%
Pancytopenia
2%
Dermoid cyst
2%
Bile duct stone
2%
Septic shock
2%
Fatigue
2%
Upper respiratory tract infection
2%
Hyperuricaemia
2%
Dyspepsia
2%
Dyspnoea
2%
Oropharyngeal discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Pegcetacoplan
Standard of Care

Trial Design

4Treatment groups
Experimental Treatment
Group I: Sham Procedure Monthly for 24 monthsExperimental Treatment1 Intervention
Sham Procedure for 24 months
Group II: Sham Procedure Every Other Month for 24 monthsExperimental Treatment1 Intervention
Sham Procedure every other month for 24 months
Group III: APL-2 15mg 0.1 mL monthly for 24 monthsExperimental Treatment1 Intervention
A single dose of 15 mg APL-2/0.1 mL will be administered via intravitreal injection in this study. Subjects will receive an injection every month
Group IV: APL-2 15mg 0.1 mL EOM for 24 monthsExperimental Treatment1 Intervention
A single dose of 15 mg APL-2/0.1 mL will be administered via intravitreal injection in this study. Subjects will receive an injection every other month
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APL-2
2018
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor
24 Previous Clinical Trials
3,404 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can sign up for this test program?

"This particular trial is not looking for new participants at this time. The date the study was first posted was August 31st, 2018 and the most recent update to the clinicaltrials.gov page was on June 20th, 2022. However, there are 329 other trials concerning geographic atrophy that are currently enrolling patients as well as 11 studies involving APL-2."

Answered by AI

Has a trial like this ever been conducted before?

"APL-2's first clinical trial was in 2018 and sponsored by Apellis Pharmaceuticals, Inc. 21 patients were included in the study. After review, APL-2 received Phase 2 drug approval which has resulted in 11 active studies taking place across 164 cities and 26 countries."

Answered by AI

Has the APL-2 drug been cleared by the FDA for consumer use?

"APL-2's safety is reflected by it being given a 3 on our team's 1 to 3 scale. This is due to this being a Phase 3 trial, where there exists some data affirming its efficacy along with multiple rounds of data supporting its safety."

Answered by AI

Is this the first time that APL-2 has been trialed?

"Right now, there are 11 clinical trials studying APL-2 with 5 of them in Phase 3. Many of the research facilities for APL-2 are based in London and California; however, 593 locations worldwide are running studies for this medication."

Answered by AI

Is this clinical trial being conducted in multiple states?

"There are a total of 77 clinical trial sites open for enrollment, these locations include Retina Consultants of Houston in The Woodlands, University of Ottawa Eye Institute in Ottawa and Retina Centre of Ottawa in Toronto."

Answered by AI

Are we able to enroll new patients at this time?

"The clinicaltrials.gov website reveals that this study is not currently looking for patients, as the last update was on 6/20/2022. Although this particular trial is no longer active, there are 340 other studies that are still recruiting participants."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
~96 spots leftby Mar 2025