RECRUITING

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

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration GA AMD Geographic atrophy Dry AMD Age-related macular degeneration

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-30

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07144137

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. Macular atrophy secondary to any condition other than AMD in the study eye. 2. 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. 3. Evidence of prior or current Choroidal Neovascularization (CNV), also known as wet-AMD, in either eye. 4. 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. 5. A history of vitrectomy in the study eye. 6. 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. 7. 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. 8. Any macular laser, macular surgery or retinal surgery at any time point in the study eye. 9. Any ocular or periocular infection in the 12 weeks prior to screening. 10. History of uveitis or endophthalmitis in either eye. 11. Any sign of diabetic retinopathy in either eye, or HbA1c \>8, in the 12 months prior to enrollment. 12. High myopia or hyperopia (≥6 diopter) in the study eye. 13. 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. 14. 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). 15. 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. 16. 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. 17. 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. 18. 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. 19. 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. 20. Hypersensitivity to medications used in (standard of care) study procedures. 21. 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). 22. 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: 23. Any previous gene or cell therapy (ophthalmic or systemic), 24. 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. Macular atrophy secondary to any condition other than AMD in the study eye.
2. 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.
3. Evidence of prior or current Choroidal Neovascularization (CNV), also known as wet-AMD, in either eye.
4. 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.
5. A history of vitrectomy in the study eye.
6. 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.
7. 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.
8. Any macular laser, macular surgery or retinal surgery at any time point in the study eye.
9. Any ocular or periocular infection in the 12 weeks prior to screening.
10. History of uveitis or endophthalmitis in either eye.
11. Any sign of diabetic retinopathy in either eye, or HbA1c \>8, in the 12 months prior to enrollment.
12. High myopia or hyperopia (≥6 diopter) in the study eye.
13. 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.
14. 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).
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. Hypersensitivity to medications used in (standard of care) study procedures.
21. 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).
22. 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:
23. Any previous gene or cell therapy (ophthalmic or systemic),
24. 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.

Contacts and Locations

Study Contact

Muhammad Ali Memon

CONTACT

+447933309143

clinicaloperations@complementtx.com

Study Locations (Sites)

Sierra Eye Associates

Reno, Nevada, 89502

United States

Collaborators and Investigators

Sponsor: Complement Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-30

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-07-30

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

GA
AMD
Geographic atrophy
Dry AMD
Age-related macular degeneration

Additional Relevant MeSH Terms

Geographic Atrophy Secondary to Age-related Macular Degeneration