Clinical trial NCT05797896: Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study
Official title: A Multicentre, Natural History, Non-interventional Study Evaluating Biomarkers In Participants With Geographic Atrophy(GA) Secondary To Age-Related Macular Degeneration (AMD)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dry Age-related Macular Degeneration
Geographic Atrophy
Retinal Disease
Macular Degeneration
Macular Atrophy
Retinal Degeneration
Eye Diseases
Keywords: Dry Age-related Macular Degeneration
Geographic Atrophy
Retinal Disease
Macular Degeneration
Macular Atrophy
Retinal Degeneration
Eye Diseases
AMD
GA
Lead sponsor: Complement Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-04-04
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 250 participants, age 65 years and older, with bilateral GA due to AMD will be accrued.

Brief summary: An observational study to investigate the natural history and evaluate biomarkers of participants with geographic atrophy secondary to age-related macular degeneration

Detailed description: Prospective, observational study to assess the relationships between circulating levels of complement proteins measured using the Complement Precision Medicine (CPM) Platform, genetic profile and lesion progression in subjects with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) up to a 24-month period

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of bilateral GA due to AMD as confirmed by fundoscopy and imaging at Screening
2. GA lesion sizes of ≥ 1.25 mm2 to ≤ 17 mm2 (approximately 1-7 disc diameters) in at least one eye as per Central Reading Center
3. Willing and able to provide written informed consent
4. Male or female aged 65 years and over

Exclusion Criteria:

1. History of neovascular (wet) AMD or presence of neovascular (wet) AMD in either eye confirmed by fundoscopy at screening and/or any pre-existing retinal imaging
2. History of intravitreal (IVT) injection in the study eye. Note: Intravitreal treatment with pegcetacoplan (Syfovre®) and avacincaptad pegol (IzervayTM) if approved within the participant's country of origin AND if deemed necessary by the Principal Investigator (PI) is allowed in the fellow eye only. IVT injections in the study eye are prohibited.
3. History of uveitis or endophthalmitis
4. High myopia (more than 6 diopter) in the study eye
5. Any ocular pathology which would impede clear imaging of the macula, e.g. intra-ocular opacities
6. Macular changes from causes other than AMD
7. Diabetic retinopathy in either eye. Note: Presence of systemic diabetes with no retinopathy is not exclusionary
8. Any other physical condition which would prevent the participant from undertaking imaging procedures
9. Any cell or gene therapy in either eye

Primary outcomes:
measure: Levels of complement proteins
timeFrame: Month 6, 12,18, 24
Secondary outcomes:
measure: Geographic Atrophy
timeFrame: Up to 24 months
measure: Genetics
timeFrame: Up to 24 months
measure: Complement Proteins Intra-individual Variation
timeFrame: Up to 24 months
measure: Complement Proteins and Progression of GA
timeFrame: Up to 24 months
measure: Choroidal Blood Flow and Genetics
timeFrame: Up to 24 months
measure: Choroidal Blood Flow and GA Lesion Progression
timeFrame: Up to 24 months
measure: CRP Levels
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Carmel
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists
state: Maryland
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Eugene
country: United States
facility: Verum Research LLC
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Plano
country: United States
facility: Texas Retina Associates
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: London
country: United Kingdom
facility: Western Eye Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary
Study officials:
affiliation: Manchester Royal Eye Hospital
name: Marta Ugarte
role: PRINCIPAL_INVESTIGATOR
References: