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

Completed

Conditions: Age-Related Macular Degeneration
Geographic Atrophy
10047518

Registration Number: NL-OMON52960

Lead Sponsor: Gyroscope Therapeutics Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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:, 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures