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Geographic AtrophyPhase 3NCT03525613

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

A Phase 3 study testing APL-2 in people with Geographic Atrophy, run by Apellis Pharmaceuticals, Inc. at 112 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Geographic Atrophy
What is being tested?
APL-2
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
637 participants
Where
112 sitesin 14 countries
Study dates
31 Aug 2018to 28 Jun 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.
  • Age ≥ 60 years.
  • Normal Luminance best corrected visual acuity of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/320 Snellen equivalent).
  • Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center.
  • The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:
Show all 21Show fewer
  • Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively)
  • If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA, as specified above in 4a.
  • The entire 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.
  • Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
  • Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
  • Meets the following criteria related to microperimetry:
  • Able to detect fixation target.
  • Total elapsed time to complete the 10-2 68 point exam is ≤ 30 minutes in duration.
  • Reliability test ratio must be ≤ 20%.
  • Subject is willing and able to undertake microperimetry assessment in the opinion of the investigator.
  • Female subjects must be:
  • Women of non-child-bearing potential (WONCBP), or
  • Women of child-bearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
  • Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
  • Willing and able to give informed consent and to comply with the study procedures and assessments.

Who cannot join

  • Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.
  • GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
  • Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.
  • Any history or active choroidal neovascularization (CNV), associated with AMD or any other cause, including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on SD-OCT imaging and/or fluorescein angiography as assessed by the Reading Center.
  • Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function, including but not limited to, uveitis, other macular diseases (e.g. clinically significant epiretinal membrane (ERM), full thickness macular hole or uncontrolled glaucoma/ocular hypertension. Benign conditions in the opinion of the investigator such as peripheral retina dystrophy are not exclusionary).
  • Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
Show all 18Show fewer
  • History of laser therapy in the macular region.
  • Aphakia or absence of the posterior capsule. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
  • Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
  • Any contraindication to IVT injection including current ocular or periocular infection.
  • History of prior intravitreal injection.
  • Unable to perform microperimetry reliably in the opinion of the investigator
  • Prior participation in another interventional clinical study for intravitreal therapies in either eye (including subjects receiving sham).
  • Prior participation in another interventional clinical study for geographic atrophy in either eye including investigational oral medication and placebo.
  • Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
  • Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 24-month treatment period unlikely, or would make the subject an unsafe study candidate.
  • Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
  • Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution.

Trial locations and contacts

112 sites in 14 countries.

112 sites in 14 countries

United States67 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Vision Research Center Eye Associates of NM

    Albuquerque, New Mexico, 87109

  • Michigan Medicine Kellogg Eye Center

    Ann Arbor, Michigan, 48105

  • Southeast Retina Center, PC

    Augusta, Georgia, 30909

  • California Retina Consultants

    Bakersfield, California, 93309

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania, 18017

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Retina Center of NJ, LLC

    Bloomfield, New Jersey, 07003

  • Gailey Eye Clinic Retina Center

    Bloomington, Illinois, 61704

  • Tufts Medical Center

    Boston, Massachusetts, 02116

  • Retinal Diagnostic Center

    Campbell, California, 95508

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Northwestern Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Blue Ocean Clinical Research / The Macula Center

    Clearwater, Florida, 33761

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Southwest Retina Research Center, LLC

    Durango, Colorado, 81301

  • Duke University, Duke Eye Center

    Durham, North Carolina, 27710

  • Research - Retina Vitreous Center

    Edmond, Oklahoma, 73013

  • Oregon Retina, LLP

    Eugene, Oregon, 97405

  • Emerson Clinical Research Institute

    Falls Church, Virginia, 22046

  • National Ophthalmic Research Institute (Retina Consultants of Southwest Florida)

    Fort Myers, Florida, 33912

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Colorado Retina Associates

    Golden, Colorado, 80401

  • Associated Retinal Consultants, P.C

    Grand Rapids, Michigan, 49564

  • Cumberland Valley Retina Center

    Hagerstown, Maryland, 21740

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland, 21740

  • Houston Eye Associates

    Houston, Texas, 77025

  • Retina Consultants of Houston, PA

    Houston, Texas, 77030

  • Atlantis Eyecare

    Huntington Beach, California, 92647

  • Midwest Eye Institute

    Indianapolis, Indiana, 46290

  • University of California, San Diego, Jacobs Retina

    La Jolla, California, 92093

  • Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • Ophthalmic Consultants of Long Island

    Lynbrook, New York, 11563

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Retina Associates New Orleans

    Metairie, Louisiana, 70006

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • VitreoRetinal Surgery PA

    Minneapolis, Minnesota, 55435

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania, 15146

  • Bascom Palmer Eye Institute of Naples

    Naples, Florida, 34103

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203

  • New York Eye and Ear Infirmary of Mount Sinai

    New York, New York, 10003

  • Vitreous Retina Macula Consultants of NY

    New York, New York, 10022

  • Byers Eye Institute at Stanford, Stanford School of Medicine

    Palo Alto, California, 94303

  • Doheny Eye Center UCLA

    Pasadena, California, 91105

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Mid Atlantic Retina, Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Arizona Retina & Vitreous Consultants

    Phoenix, Arizona, 85021

  • Retina Consultants San Diego

    Poway, California, 92064

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retinal Consultants Med Group, Inc.

    Sacramento, California, 95819

  • University of Utah - John A. Moran Center

    Salt Lake City, Utah, 84132

  • San Antonia Eye Center

    San Antonio, Texas, 78215

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retina Associates of South Texas

    San Antonio, Texas, 78240

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • Brown Retina Institute

    San Antonio, Texas, 78251

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • California Retina Consultants

    Santa Barbara, California, 93103

  • New England Retina Consultants

    Springfield, Massachusetts, 01107

  • NJ Retina

    Toms River, New Jersey, 08755

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • AIO Visionary Eye Care

    West Mifflin, Pennsylvania, 15122

  • Strategic Clinical Research Group

    Willow Park, Texas, 76087

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

France8 sites

  • CHU Dijon

    Bordeaux, 21 079

  • CHU de Bordeaux

    Bordeaux, 33076

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010

  • Clinique du Val d'Ouest

    Écully, 69130

  • Hopital Lariboisière

    Paris, 75010

  • CHNO des Quinze-Vingts

    Paris, 75012

  • Centre Ophtalmologique d'Imagerie et Laser

    Paris, 75015

  • CHU de Strasbourg Hopital Civil

    Strasbourg, 67091

Other trials in France

Germany8 sites

  • Universitäts-Augenklinik Bonn

    Bonn, 53127

  • University Opthalmology Clinic

    Freiburg im Breisgau, 79106

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen, 37075

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Augenklinik der LMU München

    München, 80336

  • Augenzentrum am St. Franziskus-Hospital

    Münster, 48145

  • Universitäts-Augenklinik

    Münster, 48149

  • STZ Eyetrial

    Tübingen, 72076

Other trials in Germany

Australia6 sites

  • Adelaide Eye & Retina Clinic

    Adelaide, South Australia, 5000

  • Lions Eye Institute

    Nedlands, Western Australia, 6009

  • Marsden Eye Specialist

    Parramatta, New South Wales, 2150

  • Strathfield Retina Clinic

    Strathfield, 2135

  • Save Sight Institute

    Sydney, South Block, 2000

  • Sydney West Retina

    Westmead, 2145

Other trials in Australia

United Kingdom4 sites

  • The Royal Victoria Hospital

    Belfast, BT12 6BA

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8XP

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP

  • York Teaching Hospital NHS Foundation Trust

    York, YO31 8HE

Other trials in United Kingdom

Israel3 sites

  • Rambam Medical Centre

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 3436212

  • Hadassah Medical Center

    Jerusalem, 91120

Other trials in Israel

Italy3 sites

  • Ospedale San Raffaele

    Milan, 20132

  • Luigi Sacco Hospital

    Milan, 20157

  • IRCCS Fondazione G.B. Bietti

    Roma, 128

Other trials in Italy

Poland3 sites

  • Oculomedica Eye Centre

    Bydgoszcz, 85-316

  • Oftalmika Eye Hospital

    Bydgoszcz, 85-631

  • Eye Surgery Center Professor Zagorski

    Rzeszów, 35-017

Other trials in Poland

Spain3 sites

  • Centro Médico Teknon

    Barcelona, 08022

  • Centro de Oftalmologia Barraquer

    Barcelona, 314

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrir, 2822

Other trials in Spain

Czechia2 sites

  • AXON Clinical S.R.O

    Prague, 150 00

  • Gemini Eye Clinic

    Zlín, 76001

Other trials in Czechia

Netherlands2 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Radboud University Medical Center Oogheelkunde

    Nijmegen, 6525

Other trials in Netherlands

Brazil1 site

  • UNIFESP - Federal University

    São Paulo, 04021-001

Other trials in Brazil

Canada1 site

  • UHN Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

New Zealand1 site

  • Southern Eye Specialists

    Christchurch, 8013

Other trials in New Zealand

About this study

Official title: A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

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.

Being tested
APL-2, Sham Procedure
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APL-2Drug

    Also called Pegcetacoplan

    Complement (C3) Inhibitor

  • APL-2Drug

    Also called Pegcetacoplan

    Complement (C3) Inhibitor

  • Sham ProcedureOther

    Subjects will receive a Sham procedure every month

  • Sham ProcedureOther

    Subjects will receive a Sham procedure every other month

Study groups in NCT03525613
Study groupRoleWhat they receive
APL-2 15mg 0.1 mL Monthly for 24 monthsExperimentalA 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
Receives: Drug: APL-2
APL-2 15mg 0.1 mL EOM for 24 monthsExperimentalA 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
Receives: Drug: APL-2
Sham Procedure Monthly for 24 monthsExperimentalSham Procedure monthly for 24 months
Receives: Other: Sham Procedure
Sham Procedure Every Other Month for 24 monthsExperimentalSham Procedure every other month for 24 months
Receives: Other: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12

    The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure (MMRM) model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.

    Measured: Baseline (screening) and Month 12

Secondary outcomes (6)

  1. LS Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 24

    The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.

    Measured: Baseline (screening) and Month 24

  2. Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24

    The mean change in GA lesion area through Month 24 was measured by assuming a piecewise linear trend in time with knots by FAF images at Months 6, 12, 18, and 24 and was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.

    Measured: From Baseline (screening) through Month 24

  3. LS Mean Change From Baseline in Mean Threshold Sensitivity of All Points of the Study Eye at Month 24

    Mean threshold sensitivity of all points was determined from the mesopic microperimetry as an assessment of the macular functional response. Microperimetry offers the option to test retinal light sensitivity while directly observing the fundus and allows for monitoring of macular function loss associated with GA progression. The microperimetry reading center overlaid the baseline FAF images with GA lesions traced by the imaging reading center and the corresponding macular integrity assessment microperimetry baseline scanning laser ophthalmoscope image and identified perilesional (within 500 microns outside the atrophy border), paralesional (beyond 500 microns outside the atrophy border), and extralesional (outside the atrophy border) loci on the microperimetry grid to determine the mean threshold sensitivity for these 3 areas. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.

    Measured: Baseline (screening) and Month 24

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

    The maximum reading speed of the study eye was calculated per Minnesota Low-Vision Reading Test (MNREAD) or Radner Reading Charts user manuals, with no adjustment for reading inaccuracy. An additional step to cap resulting reading speed values at a maximum of 300 words per minute (wpm) was implemented. Maximum reading speed was calculated as the mean of the 3 highest non-zero reading speeds (or 2, or 1 value, as available), except when all wpm were calculated as 0 then the maximum reading speed was calculated as 0. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.

    Measured: Baseline (screening) and Month 24

  5. LS Mean Change From Baseline in Mean Functional Reading Independence (FRI) Index Score at Month 24

    The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD subjects. It had 1 total index score. For each FRI Index reading activity performed in the past 7 days, subjects were asked about the extent to which they required assistance beyond eyeglasses/contact lenses, including the use of low-vision aids, adjustments in the activity, or help from another subject. Mean FRI Index scores ranged from 1 (unable to do independently) to 4 (totally independent), with higher scores indicating higher functional reading independence. A negative change from baseline indicated a decrease in the FRI; disease worsening. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.

    Measured: Baseline (screening) and Month 24

  6. LS Mean Change From Baseline in Normal-Luminance Best-Corrected Visual Acuity (NL-BCVA) Score of the Study Eye at Month 24

    The NL-BCVA was assessed by early treatment diabetic retinopathy study (ETDRS) chart prior to dilating the eyes at a starting distance of 4 meters and ranged from 0 (least score) to 100 (best score). If the 4-meter score was >19 letters read correctly, the visual acuity score was the sum of total letters correctly read at 4 meters plus the addition of 30. If the 4-meter score was ≤19 letters read correctly, the visual acuity score was the sum of total letters read correctly at 4 meters and total letters read correctly at the 1-meter distance. If no letters were read correctly at either the 4-meter distance or the 1-meter distance, the visual acuity score was 0. A positive change in the value indicated improvement in visual acuity. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.

    Measured: Baseline (screening) and Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2018
  2. Study start31 Aug 2018
  3. Primary completion28 Jun 2021
  4. Study completion28 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
637 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525613
Sponsor's protocol ID
APL2-304
Status last verified
Jun 2023
First submitted
20 Apr 2018
Last updated
6 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Birner K, Mai J, Boryshchuk D, Frommlet F, Enzendorfer ML, Schurer-Waldheim S, Gumpinger M, Vogl WD, Leingang O, Sacu S, Schmidt-Erfurth U. Exploring Trial Endpoints in Geographic Atrophy Based on Localized Functional Changes in Microperimetry and AI-Quantified OCT Biomarkers. Invest Ophthalmol Vis Sci. 2026 Jan 5;67(1):22. doi: 10.1167/iovs.67.1.22.

    PubMed 41533918

  • Sadda S, Hatcher KA, Shah BK, Kondapalli SS, Li C, Baumal CR. Outer Retinal Tubulation and Geographic Atrophy: A Natural History Analysis of Sham Observed Eyes from the OAKS and DERBY Trials. Ophthalmol Ther. 2025 Jul;14(7):1611-1619. doi: 10.1007/s40123-025-01156-5. Epub 2025 May 19.

    PubMed 40388106

  • Wykoff CC, Lad EM, Heier JS. Syfovre Approval for Geographic Atrophy. JAMA Ophthalmol. 2024 Jul 1;142(7):685-686. doi: 10.1001/jamaophthalmol.2024.1754. No abstract available.

    PubMed 38814626

  • Fu DJ, Bagga P, Naik G, Glinton S, Faes L, Liefers B, Lima R, Wignall G, Keane PA, Ioannidou E, Ribeiro Reis AP, McKeown A, Scheibler L, Patel PJ, Moghul I, Pontikos N, Balaskas K. Pegcetacoplan Treatment and Consensus Features of Geographic Atrophy Over 24 Months. JAMA Ophthalmol. 2024 Jun 1;142(6):548-558. doi: 10.1001/jamaophthalmol.2024.1269.

    PubMed 38722644

  • Heier JS, Lad EM, Holz FG, Rosenfeld PJ, Guymer RH, Boyer D, Grossi F, Baumal CR, Korobelnik JF, Slakter JS, Waheed NK, Metlapally R, Pearce I, Steinle N, Francone AA, Hu A, Lally DR, Deschatelets P, Francois C, Bliss C, Staurenghi G, Mones J, Singh RP, Ribeiro R, Wykoff CC; OAKS and DERBY study investigators. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials. Lancet. 2023 Oct 21;402(10411):1434-1448. doi: 10.1016/S0140-6736(23)01520-9.

    PubMed 37865470

  • Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.

    PubMed 37314061

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing APL-2 in people with Geographic Atrophy, run by Apellis Pharmaceuticals, Inc. at 112 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, France, Germany, Australia, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12 (time frame: Baseline (screening) and Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03525613, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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