Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration

Completed · Phase 1/Phase 2

Conditions studied: Age-related Macular Degeneration

In brief

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).

Key facts

Study ID

NCT02140151

Run by

Southern California Desert Retina Consultants, MC

People needed

108

Starts

2014-09-17

Expected to finish

2020-07-09

Last updated by the study team

2022-08-25

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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