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COMPLETED Phase 3

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

NCT03525600 · View on ClinicalTrials.gov ↗

Study Summary

This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

Conditions Studied

Interventions

  • OTHER Sham Procedure
  • DRUG APL-2

Study Locations (20)

California

  • Retina Institute of California dba Acuity Eye Grp — Arcadia
  • California Retina Consultants — Bakersfield
  • Retina Vitreous Associates Medical Group — Beverly Hills
  • The Retina Partners — Encino
  • The Gavin Herbert Eye Institute/UC Irvine — Irvine
  • Northern California Retina Vitreous Associates — Mountain View
  • Retina Institute of California Medical Group — Palm Desert
  • Byers Eye Institute at Standford, Stanford School of Medicine — Palo Alto
  • Retina Consultants San Diego — Poway
  • Retina Consultants of Southern California — Redlands
  • California Retina Consultants — Santa Barbara
  • Bay Area Retina Associates — Walnut Creek

Connecticut

  • Danbury Eye Physicians & Surgeons, P.C. - Danbury — Danbury
  • New England Retina Associates — Hamden
  • Retina Group of New England,PC — Waterford

Florida

  • Florida Eye Microsurgical Institute, Inc. — Boynton Beach
  • Pinnacle Research Institute — Fort Lauderdale
  • Retina Health Center — Fort Myers

Arizona

  • Retinal Research Institute — Phoenix
  • Associated Retina Consultants, Ltd — Phoenix

Trial Details

FieldValue
Enrollment Target 621 participants
Start Date 2018-08-31
Est. Completion 2022-06-20
Phase Phase 3

Sponsor

Apellis Pharmaceuticals

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03525600

The ClinicalTrials.gov registry entry for NCT03525600 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 621 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Apellis Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Geographic Atrophy appearing as the primary indexed condition, and to 2 interventions — of which Sham Procedure is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03525600 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Connecticut, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03525600 about?

NCT03525600 is a clinical study titled "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". This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

What is the current status of trial NCT03525600?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 621 participants. The study started on 2018-08-31. Estimated completion is 2022-06-20.

What conditions does trial NCT03525600 study?

This clinical trial studies the following conditions: Geographic Atrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03525600?

The interventions under investigation include: Sham Procedure (OTHER), APL-2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03525600?

This trial is sponsored by Apellis Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03525600 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial