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Geographic Atrophy Secondary to Age-related Macular DegenerationPre-GAINNCT07144137

A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA)

An observational study of Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Complement Therapeutics at 19 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a non-interventional, observational study to provide insights into the short-term progression of GA secondary to AMD in participants aged ≥55 years. This is a multi-center, non-interventional, observational study which aims to identify participants who have progressive GA to allow quantification of structural… Read more about this study

Who is it for?
Ages 55 years and older
How many people
75 participants
Where
19 sitesin 2 countries
Study dates
30 Jul 2025to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Male or female participants, aged ≥55 years, with GA secondary to AMD are considered the appropriate population. This represents the lower end of the age range for the population with GA secondary to AMD with appropriately advanced disease to enable the measurement of disease progression. Participants with bilateral GA are selected to minimize the risk of developing neovascular (wet) AMD during the study and to allow the collection of data and potential comparison of progression for 2 eyes for each participant.

Who may be able to join

  • Participants must be aged ≥55 years, at the time of signing the informed consent at the screening visit.
  • Participants with bilateral GA secondary to AMD as confirmed by the Central Reading Center using FAF and/or OCT images with at least 1 eye having a total GA lesion area must be between 1.25 mm2 and 17.5 mm2 inclusive, determined by FAF images taken at the screening visit.
  • Best-corrected visual acuity (BCVA) in both eyes should be sufficient to ensure navigational vision (defined as 20/400 or better for purposes of this study).
  • BCVA between 20 and 75 letters and LLVA>0 letters using an ETDRS chart.
  • Mean retinal sensitivity as measured by microperimetry using the study grid must be equal to or greater than 5 dB.
  • Able and willing to provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, and in the opinion of the investigator, is able to perform all study assessments.

Who cannot join

  • Macular atrophy secondary to any condition other than AMD in the study eye.
  • Any pathology of the macula other than GA secondary to AMD and other changes consistent with early, intermediate or atrophic AMD in the study eye.
  • Evidence of prior or current Choroidal Neovascularization (CNV), also known as wet-AMD, in either eye.
  • Atrophic retinal disease of causality other than AMD including monogenetic macular dystrophies (incorporating pattern dystrophy), myopia-related maculopathy and Stargardt disease in the study eye.
  • A history of vitrectomy in the study eye.
  • Any prior treatment for AMD or any prior intravitreal treatment for any indication in the study eye, except oral supplements of vitamins and minerals such as the age-related eye disease study (AREDS) formula.
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  • Any intraocular surgery (except cataract surgery within 6 months of enrollment) or thermal laser within 3 months of screening, or any ophthalmic condition that may require surgery during the study.
  • Any macular laser, macular surgery or retinal surgery at any time point in the study eye.
  • Any ocular or periocular infection in the 12 weeks prior to screening.
  • History of uveitis or endophthalmitis in either eye.
  • Any sign of diabetic retinopathy in either eye, or HbA1c >8, in the 12 months prior to enrollment.
  • High myopia or hyperopia (≥6 diopter) in the study eye.
  • Uncontrolled IOP measurement of ≥25 mmHg for >1 month despite being on 2 or more ocular hypotensive agents, or IOP >21 mm Hg in the presence of C/D asymmetry of >0.3 per the reading center; or glaucomatous damage to the optic nerve or visual field.
  • Retinal disease other than AMD or other ocular disorders which may cause safety concerns per the judgment of the investigator; however, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., paving stone degeneration).
  • Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination (e.g., cataract or corneal abnormalities) either at the time of enrollment or during the 2-year post dosing follow-up period; or prevents adequate imaging of the retina judged by the site or CRC.
  • Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to baseline.
  • Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the treatment period unlikely, or in general a poor medical risk because of other systemic diseases or active uncontrolled infections, including but not limited to immunodeficiency state, autoimmune diseases, malignancy other than prostate or basal cell carcinoma, connective tissue disorders and collagen vascular disorders.
  • Participation in an interventional clinical study, or use of any experimental treatment for AMD or any investigational product within 6 months or 5 half-lives of the active ingredient (whichever is longer) prior to screening.
  • History of abnormal laboratory tests (e.g. hematology, serum chemistry, renal or liver function tests, or infectious disease screen) that in the opinion of the investigator is clinically significant at the time of enrollment and not suitable for study participation.
  • Hypersensitivity to medications used in (standard of care) study procedures.
  • Situations where, in the opinion of the investigator, the risk of harm to a participant outweighs any potential benefits from study participation (these could include participants with conditions such as brittle diabetes or advanced osteoporosis as examples).
  • History or current use of medications associated with macular changes, retinal dysfunction or optic nerve damage. These include but are not limited to the following prohibited concomitant medications:
  • Any previous gene or cell therapy (ophthalmic or systemic),
  • Chloroquine (where taken for >30 days cumulative across participant's lifetime), hydroxychloroquine, platinum containing medications, ethambutol, tamoxifen, pentosan, chronic use of phosphodiesterase inhibitors, and GLP-1 antagonists in the setting of a crowded optic disc.

Trial locations and contacts

19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Muhammad Ali Memon contact

clinicaloperations@complementtx.com

19 sites in 2 countries

United States10 sites, 8 recruiting

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania, 18017

    Recruiting

  • Midwest Eye Institute

    Carmel, Indiana, 46032

    Withdrawn

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

    Recruiting

  • Duke Eye Center

    Durham, North Carolina, 27710

    Recruiting

  • Gundersen Health System

    La Crosse, Wisconsin, 54601

    Recruiting

  • Northern California Retina Vitreous Associates Medical Group

    Mountain View, California, 94040

    Active, not recruiting

  • University Retina and Macula Associates

    Oak Forest, Illinois, 60452

    Recruiting

  • Sierra Eye Associates

    Reno, Nevada, 89502

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62703

    Recruiting

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587

    Recruiting

Other trials in United States

United Kingdom9 sites, 9 recruiting

  • Belfast City Hospital

    Belfast, BT9 7AB

    Recruiting

  • Frimley Park Hospital

    Frimley, GU16 7UJ

    Recruiting

  • Gloucestershire Royal Hospital

    Gloucester, Gloucester, GL1 3NN

    Recruiting

  • Moorfields Eye Hospital

    London, London, EC1V 2PD

    Recruiting

  • Central Middlesex Hospital

    London, London, NW10 7NS

    Recruiting

  • The Retina Clinic London

    London, W1G 7LB

    Recruiting

  • Manchester Royal Eye Hospital

    Manchester, M13 9WL

    Recruiting

  • University Hospital Southampton

    Southampton, Southampton, SO16 6YD

    Recruiting

  • Sunderland Eye lnfirmary

    Sunderland, Sunderland, SR2 9HP

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

This is a non-interventional, observational study to provide insights into the short-term progression of GA secondary to AMD in participants aged ≥55 years.

This is a multi-center, non-interventional, observational study which aims to identify participants who have progressive GA to allow quantification of structural and functional parameters that characterize the progression of GA, and to investigate whether these correlate with genetic or lifestyle factors.

Keywords
GA, AMD, Geographic atrophy, Dry AMD, Age-related macular degeneration
Medical subject headings
Geographic Atrophy, Macular Degeneration

What is being measured

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

  1. Short-term GA Progression

    To quantify the structural and functional parameters of short-term progression of geographic atrophy (GA) through clinical evaluation and investigations

    Measured: Baseline, Month 3, Month 6

Secondary outcomes (1)

  1. Further exploration of GA progression

    To further explore selected potential correlates of structural and functional parameters of GA progression in greater depth

    Measured: Baseline, Month 3, Month 6

Timeline

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

  1. First posted27 Aug 2025
  2. Study start30 Jul 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07144137
Sponsor's protocol ID
IGS02
Acronym
Pre-GAIN
Status last verified
Oct 2026
First submitted
20 Aug 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Complement Therapeutics at 19 sites in 2 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 6 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, United Kingdom. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Muhammad Ali Memon (clinicaloperations@complementtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short-term GA Progression (time frame: Baseline, Month 3, Month 6). 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 NCT07144137.

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 16 Oct 2026.

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