A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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ClinicalTrials.gov Identifier: NCT02399072 |
Recruitment Status :
Terminated
(There is no longer a plan to pursue an approval of lampalizumab.)
First Posted : March 26, 2015
Last Update Posted : August 9, 2019
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Condition or disease | Intervention/treatment |
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Geographic Atrophy | Other: No intervention |
Study Type : | Observational |
Actual Enrollment : | 202 participants |
Official Title: | A Multicenter, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration |
Actual Study Start Date : | March 30, 2015 |
Actual Primary Completion Date : | February 8, 2018 |
Actual Study Completion Date : | February 8, 2018 |

Group/Cohort | Intervention/treatment |
---|---|
Geographic Atrophy Participants
Participants with unilateral GA or GA in one eye and choroidal neovascularization (CNV; active or treated) with or without GA, in the contralateral eye, will be evaluated for the progression of GA for up to approximately 60 months.
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Other: No intervention
No intervention administered in this study |
- Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Change from Baseline in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Change from Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Cards or Radner Reading Cards up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Change from Baseline in Monocular Reading Speed as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Change from Baseline in Binocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Change from Baseline in Monocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Change from Baseline in Near Activity Subscale as Assessed by National Eye Institute Visual Functioning Questionnaire 25-Item Version (NEI VFQ-25) up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Change from Baseline in Distance Activity Subscale as Assessed by NEI VFQ-25 up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Change from Baseline in Composite Scores as Assessed by NEI VFQ-25 up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Change from Baseline in Functional Reading Independence Score up to Month 60 [ Time Frame: Baseline up to Month 60 ]
- Percentage of Participants With Medical Events [ Time Frame: Baseline up to Month 60 ]
- Percentage of Participants With Ocular Events [ Time Frame: Baseline up to Month 60 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Well-demarcated area of GA secondary to AMD
- Women of childbearing potential and men must agree to use adequate contraception for at least 30 days after fluorescein dye administration
- The study is recruiting participants in two different cohorts:
Cohort 1: Participants with unilateral GA OR Cohort 2: Participants with GA in one eye and CNV (active or treated) with or without GA, in the contralateral eye
Exclusion Criteria:
- Previous participation in any studies of investigational drugs for GA / dry AMD (exception 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/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

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): NCT02399072

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02399072 |
Other Study ID Numbers: |
GX29639 2014-003940-11 ( EudraCT Number ) GX29639 ( Other Identifier: Hoffmann-La Roche ID ) |
First Posted: | March 26, 2015 Key Record Dates |
Last Update Posted: | August 9, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Macular Degeneration Geographic Atrophy Atrophy Retinal Degeneration |
Retinal Diseases Eye Diseases Pathological Conditions, Anatomical |