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

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ClinicalTrials.gov Identifier: NCT02479386
Recruitment Status : Terminated (There is no longer a plan to pursue an approval of lampalizumab.)
First Posted : June 24, 2015
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Geographic Atrophy Other: No intervention

Study Design
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Study Type : Observational
Actual Enrollment : 296 participants
Official Title: A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration
Actual Study Start Date : June 24, 2015
Actual Primary Completion Date : April 14, 2017
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort Geographic Atrophy
Cohort of participants with GA secondary to AMD will be evaluated for changes in GA over time.
 Other: No intervention
No intervention was administered in this study.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479386


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02479386    
Other Study ID Numbers: GX29633
2014-003939-19 ( EudraCT Number )
GX29639 ( Other Identifier: Hoffmann-La Roche ID )
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical