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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02479386
• Date of registration: 19/06/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Proxima A
• Scientific title: A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration
• Date of first enrolment: June 24, 2015
• Target sample size: 296
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02479386
• Study type: Observational

Countries of recruitment

Argentina, Australia, Austria, Brazil, Canada, France, Germany, Greece, Hungary, Israel, Italy, Poland, Spain, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods that result in a failure rate
of less than (<) 1 percent (%) per year for at least 30 days after the last
fluorescein dye administration

- The study is being conducted in participants with GA in both Study Eye and Non-Study
Eye (bilateral GA) with no evidence of prior or active choroidal neovascularization
(CNV)

Exclusion Criteria:

- Previous participation in any studies of investigational drugs for GA or dry AMD
(except for studies of vitamins and minerals)

- GA in either eye due to causes other than AMD

- History of vitrectomy surgery, submacular surgery, or any surgical intervention for
AMD

- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein
occlusion, and/or proliferative diabetic retinopathy

- Any ocular or systemic medical conditions that, in the opinion of the investigator,
could contribute to participant's inability to participate in the study or interfere
with study assessments

- Requirement for continuous use of therapy indicated in Prohibited Therapy in the study
Protocol



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Geographic Atrophy

Intervention(s)

Other: No intervention

Primary Outcome(s)

Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards [Time Frame: Baseline up to end of study (up to approximately 48 months)]

Monocular and Binocular Reading Speed as Assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards [Time Frame: Baseline up to end of study (up to approximately 48 months)]

Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart [Time Frame: Baseline up to end of study (up to approximately 48 months)]

Macular Sensitivity as Assessed by Mesopic MP [Time Frame: Baseline up to end of study (up to approximately 48 months)]

Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP) [Time Frame: Baseline up to end of study (up to approximately 48 months)]

BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions [Time Frame: Baseline up to end of study (up to approximately 48 months)]

Secondary Outcome(s)

Change from Baseline in Functional Reading Independence (FRI) Index Score [Time Frame: Baseline, end of study (up to approximately 48 months)]

Change from Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) Score [Time Frame: Baseline, end of study (up to approximately 48 months)]

Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF) [Time Frame: Baseline, end of study (up to approximately 48 months)]

Percentage of Participants With Medical Events of Interest (MEIs) [Time Frame: Baseline up to end of study (up to approximately 48 months)]

Secondary ID(s)

GX29633

2014-003939-19

GX29639

Source(s) of Monetary Support

Please refer to primary and secondary sponsors