Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration
NCT ID: NCT02140151
Last Updated: 2022-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
108 participants
INTERVENTIONAL
2014-09-17
2020-07-09
Brief Summary
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Detailed Description
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The objective of this study is to investigate the safety and efficacy of prophylactic anti-vascular endothelial growth factor (VEGF) therapy with ranibizumab to prevent the development of exudative AMD in eyes with high-risk nonexudative AMD. In addition, baseline characteristics of high-risk eyes (fundus features, optical coherence tomography (OCT) parameters and genetic profile) will be evaluated to determine their predictive value in conversion to exudative AMD. The effect of ranibizumab on the atrophic component of AMD will also be monitored.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Sham
Sham Injection
No interventions assigned to this group
Quarterly Ranibizumab 0.5mg
Quarterly intravitreal injection of 0.5mg ranibizumab
Ranibizumab 0.5mg
Interventions
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Ranibizumab 0.5mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to sign informed consent and comply with the study protocol for the duration of two years
* Nonexudative age-related macular degeneration (AMD) in one eye (study eye)
* History of exudative AMD in one eye only (fellow eye) diagnosed within 5 years of study enrollment
Exclusion Criteria
* Patient is pregnant, lactating, or premenopausal and not using adequate contraception
* Known serious allergies to ranibizumab, fluorescein dye, drugs for pupillary dilation, topical anesthetic, sterilizing solution (e.g. Betadine solution)
* Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters or axial length of ≥ 25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), idiopathic central serous chorioretinopathy (ICSC), etc.
* History of vitrectomy in the study eye
* History of cataract surgery within 3 months of enrollment
* History of yttrium aluminum garnet (YAG) capsulotomy within 1 month of enrollment
* History of intraocular or periocular corticosteroid therapy within the past 90 days
* History of therapeutic radiation in the region of the study eye.
* Presence of media opacity that would preclude adequate examination and/or imaging
* Concurrent macular conditions that would affect the study parameters (epiretinal membrane, macular hole, macular edema) or require treatment within the duration of the study
* Any progressive ocular condition (uncontrolled glaucoma, diabetic retinopathy, uveitis) that may affect the visual acuity for the duration of the study
* Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at enrollment
* Presence of any advanced systemic condition that may hinder the patients participation and completion of the study
* Concurrent use of systemic anti-VEGF therapy
50 Years
ALL
No
Sponsors
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Southern California Desert Retina Consultants, MC
OTHER
Responsible Party
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Principal Investigators
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Maziar Lalezary, MD
Role: PRINCIPAL_INVESTIGATOR
Southern California Desert Retina Consultants
Locations
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Northern California Retina Vitreous Associates
Mountain View, California, United States
Southern California Desert Retina Consultants
Palm Desert, California, United States
Elman Retina
Baltimore, Maryland, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Countries
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Other Identifiers
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ML29258
Identifier Type: -
Identifier Source: org_study_id
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