NCT07144137

Brief 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 and functional parameters that characterize the progression of GA, and to investigate whether these correlate with genetic or lifestyle factors.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Jul 2025

Geographic Reach
2 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jul 2025Jun 2027

Study Start

First participant enrolled

July 30, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

August 20, 2025

Last Update Submit

May 1, 2026

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Keywords

GAAMDGeographic atrophyDry AMDAge-related macular degeneration

Outcome Measures

Primary Outcomes (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

    Baseline, Month 3, Month 6

Secondary Outcomes (1)

  • Further exploration of GA progression

    Baseline, Month 3, Month 6

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Northern California Retina Vitreous Associates Medical Group

Mountain View, California, 94040, United States

RECRUITING

Midwest Eye Institute

Carmel, Indiana, 46032, United States

RECRUITING

Sierra Eye Associates

Reno, Nevada, 89502, United States

RECRUITING

Mid Atlantic Retina

Bethlehem, Pennsylvania, 18017, United States

RECRUITING

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

RECRUITING

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

RECRUITING

Gloucestershire Royal Hospital

Gloucester, Gloucester, GL1 3NN, United Kingdom

RECRUITING

Moorfields Eye Hospital

London, London, EC1V 2PD, United Kingdom

RECRUITING

The Retina Clinic London

London, W1G 7LB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Geographic AtrophyMacular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Central Study Contacts

Muhammad Ali Memon

CONTACT

clinicaloperations@complementtx.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2025

First Posted

August 27, 2025

Study Start

July 30, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

May 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)US(6)