An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy
Status: | Terminated |
---|---|
Healthy: | No |
Age Range: | 60 - 89 |
Updated: | 2/23/2019 |
Start Date: | May 29, 2012 |
End Date: | February 9, 2018 |
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed Genentech-Sponsored Lampalizumab Studies
This is a multicenter, open-label extension study of safety and tolerability of lampalizumab
administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who
have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week
treatment in Study GX29455 (NCT02288559).
administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who
have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week
treatment in Study GX29455 (NCT02288559).
Inclusion Criteria:
- For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of
Study CFD4870g without early treatment discontinuation (lampalizumab or sham)
- For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study
GX29455 without early treatment discontinuation (lampalizumab or sham)
- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit
quality fundus imaging
Exclusion Criteria:
- Early treatment and/or study discontinuation prior to completion of study CFD4870g
(GX01456) and GX29455
- Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related
macular degeneration (AMD) in the study eye
- Subfoveal focal laser photocoagulation in the study eye
- Treatment with Visodyne, external-beam radiation therapy, or transpupillary
thermotherapy in the study eye
- Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection,
anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye.
Lampalizumab in study eye and ranibizumab in either eye are permitted
- Any concurrent ocular or intraocular condition in the study eye that contraindicates
the use of an investigational drug or may affect interpretation of the study results
or may render the participant at high risk for treatment complications
We found this trial at
42
sites
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25 Sigmund-Freud-Straße
Bonn, 53127
Bonn, 53127
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Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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