Skip to main content
OpenTrials
Terminated

NCT Number: NCT02479386

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

This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study is also intended to generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 48 months. There is a planned interim analysis around the 2-year time window for the study.

Terminated

Looking for future studies?

Notify Me

Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Organizacion Medica de Investigacion, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention was administered in this study.

Primary outcomes

  1. Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP)

    Time frame: Baseline up to end of study (up to approximately 48 months)

  2. Macular Sensitivity as Assessed by Mesopic MP

    Time frame: Baseline up to end of study (up to approximately 48 months)

  3. 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)

  4. BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions

    Time frame: Baseline up to end of study (up to approximately 48 months)

  5. 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)

  6. 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)

Secondary outcomes

  1. Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF)

    Time frame: Baseline, end of study (up to approximately 48 months)

  2. 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)

  3. Change from Baseline in Functional Reading Independence (FRI) Index Score

    Time frame: Baseline, end of study (up to approximately 48 months)

  4. Percentage of Participants With Medical Events of Interest (MEIs)

    Time frame: Baseline up to end of study (up to approximately 48 months)

    The clinical events (cardiovascular, respiratory, cognitive, ocular events etc.) occurring during the study are termed as MEIs. These events will be collected using MEI electronic Case Report Form (eCRF) checklist.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

Acronym: Proxima A

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 24, 2015
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.