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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (screening) and month 24

Awards & highlights

Study Summary

This trial will test if a new treatment for age-related macular degeneration is effective and safe.

Eligible Conditions

Age-Related Macular Degeneration (AMD)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (screening) and month 24

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 Mean Threshold Sensitivity of All Points of the Study Eye at Month 24

LS Mean Change From Baseline in Monocular Maximum Reading Speed of the Study Eye at Month 24

+3 more

Side effects data

From 2021 Phase 3 trial • 53 Patients • NCT04085601

13%

Pain in extremity

13%

Hypokalaemia

11%

Arthralgia

11%

Dizziness

Pyrexia

Headache

Ecchymosis

Thrombocytopenia

Erythema

Viral infection

Anaemia

Haemolysis

Musculoskeletal pain

Abdominal pain

Abdominal pain upper

Cough

Epistaxis

Somnolence

Blood creatinine increased

Dyspnoea

Bile duct stone

Septic shock

Oropharyngeal discomfort

Rhinitis allergic

Fatigue

Febrile neutropenia

Neutropenia

Pancytopenia

Dermoid cyst

Upper respiratory tract infection

Hyperuricaemia

Dyspepsia

100%

80%

60%

40%

20%

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 monthly 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor

24 Previous Clinical Trials

3,388 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 will be able to enroll in this trial?

"This trial has completed recruitment for participants. The study was first posted on 8/30/2018, with the most recent update on 6/20/2022. However, there are 328 trials actively recruiting patients with geographic atrophy and 11 studies for APL-2 that are presently looking for participants."

Answered by AI

Is this the first time APL-2 has been tested in a human clinical trial?

"There are 11 ongoing studies regarding APL-2, 5 of which are in the final stage of testing before release. The trials are being conducted in 593 different locations, with a notable presence in London and California."

Answered by AI

Has the FDA cleared APL-2 for patient use?

"There is some evidence from previous trials to support the efficacy of APL-2, and it has been shown to be safe in multiple rounds of testing, so it received a score of 3."

Answered by AI

To the best of your knowledge, does a similar study exist?

"There are 11 ongoing clinical trials for APL-2 in 164 cities and 26 countries. The first one began in 2018 and, sponsored by Apellis Pharmaceuticals, Inc., it involved 21 patients. All participants completed the Phase 2 drug approval stage. As of now, a total of 30 trials have been completed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration

2018. "A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03525613.