A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration

A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration - GTSCOPE study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52960

Enrollment

Registered

2019-07-03

Start date

2019-11-01

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration Geographic Atrophy

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria:, 1. Aged >=18 years, 2. Able and willing to give consent to study participation, 3. Presence of unilateral or bilateral GA due to AMD, 4. The GA lesion in at least one eye must reside completely within the FAF image, 5. For Group 1, subjects will be required to have a serum CFI level below the lower limit of the assay together with a rare genetic variant of the CFI gene OR for Group 2, subjects will have a genetic variant of a complement factor gene and do not qualify for Group 1, 6. Able to attend all study visits and complete the study procedures, 7. BCVA of 40 letters or better using ETDRS charts in the eye that meets inclusion criterion 3

Exclusion criteria

Exclusion criteria: Exclusion Criteria:, 1. Evidence or history of neovascular AMD or diabetic retinopathy; previous intravitreal drug delivery [either eye] received within 4 weeks or 5 half-lives whichever is longer, before screening/baseline visit, 2. Any other significant ocular or non-ocular disease/disorder which, in the opinion of the investigator, may influence the results of the study, or the subject*s ability to participate in the study, 3. Participation in another research study involving an investigational product within the previous 4 weeks or 5 half-lives whichever is longer, from the screening/baseline visit OR received a gene/cell therapy at any time previously

Design outcomes

Primary

Measure	Time frame
The following endpoints will be assessed: - GA area size as assessed by Fundus Autofluorescence (FAF) - Best Corrected Visual Acuity (BCVA) Score as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart in standard and low luminance conditions - Rate of GA progression based on anatomical findings on colour fundus photography and Spectral Domain Optical Coherence Tomography (SD- OCT) - Monocular and Binocular Reading Speed as assessed by Minnesota Low-Vision Reading Test (MNRead) Chart - Quality of life (QoL) score as measured by National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) - Retinal sensitivity as assessed by microperimetry - Percentage of Participants with Medical Events of Interest (MEIs)	—

Measure

Time frame

The following endpoints will be assessed: - GA area size as assessed by Fundus Autofluorescence (FAF) - Best Corrected Visual Acuity (BCVA) Score as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart in standard and low luminance conditions - Rate of GA progression based on anatomical findings on colour fundus photography and Spectral Domain Optical Coherence Tomography (SD- OCT) - Monocular and Binocular Reading Speed as assessed by Minnesota Low-Vision Reading Test (MNRead) Chart - Quality of life (QoL) score as measured by National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) - Retinal sensitivity as assessed by microperimetry - Percentage of Participants with Medical Events of Interest (MEIs)

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Countries

Netherlands

Outcome results