Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration
United States108 participantsStarted 2014-09-17
Plain-language summary
This study will determine whether quarterly injections of Ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration (AMD).
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Adult over 50 years old
* 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:
* Participation in another simultaneous medical investigation or clinical trial
* 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…
What they're measuring
1
Development of exudative AMD
Timeframe: 2 years
Trial details
NCT IDNCT02140151
SponsorSouthern California Desert Retina Consultants, MC