Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study

Macular Degeneration Clinical Trial

— i-GAIN  

Official title:

A Multicentre, Natural History, Non-interventional Study Evaluating Biomarkers In Participants With Geographic Atrophy(GA) Secondary To Age-Related Macular Degeneration (AMD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797896
• Other study ID #: IGS01
• Secondary ID: i-GAIN
• Status: Recruiting
• Start date: February 7, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Complement Therapeutics
• Contact: Marta Ugarte
• Phone: 0161 701 2589
• Email: marta.ugarte[@]mft.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Dry Age-related Macular Degeneration
• Eye Diseases
• Geographic Atrophy
• Macular Atrophy
• Macular Degeneration
• Retinal Degeneration
• Retinal Disease
• Retinal Diseases

Locations

Country	Name	City	State
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Frimley Park Hospital	Frimley
United Kingdom	Gloucestershire Royal Hospital	Gloucester
United Kingdom	Liverpool Hospital	Liverpool
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	Western Eye Hospital	London
United Kingdom	Manchester Royal Eye Hospital	Manchester
United Kingdom	Newcastle Hospital	Newcastle
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	University Hospital Southampton	Southampton
United Kingdom	Sunderland Eye Infirmary	Sunderland
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Midwest Eye Institute	Carmel	Indiana
United States	Verum Research LLC	Eugene	Oregon
United States	Global Research Management	Glendale	California
United States	Mid Atlantic Retina Specialists	Hagerstown	Maryland
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Retina Service of Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Texas Retina Associates	Plano	Texas
United States	Sierra Eye Associates	Reno	Nevada
United States	San Antonio Eye Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Complement Therapeutics

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of complement proteins	To assess the correlation between circulating levels of complement proteins measured using the Complement Precision Medicine (CPM) Platform and Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD)	Month 6, 12,18, 24
Secondary	Geographic Atrophy	To investigate whether there is a relationship between progression of GA and complement profile measured using the CPM platform	Up to 24 months
Secondary	Genetics	To investigate the relationship between variants in genes or loci associated with AMD and the complement profile measured using the CPM platform	Up to 24 months
Secondary	Complement Proteins Intra-individual Variation	To determine the intra-individual variation in complement profile using the Complement Precision Medicine (CPM) Platform, in participants with GA	Up to 24 months
Secondary	Complement Proteins and Progression of GA	To investigate whether there is a relationship between progression of GA and complement profile measured using the Complement Precision Medicine (CPM) platform	Up to 24 months
Secondary	Choroidal Blood Flow and Genetics	To investigate the relationship in genes or loci associated with AMD and choroidal blood flow and structure	Up to 24 months
Secondary	Choroidal Blood Flow and GA Lesion Progression	To investigate the relationships between choroidal blood flow and structure and GA lesion progression	Up to 24 months
Secondary	CRP Levels	To observe the influence of any past or concurrent illnesses, in particular inflammation-related illnesses, rise in serum CRP or of any medications on complement profile using the CPM Platform	Up to 24 months