Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration (PREVENT)

Southern California Desert Retina Consultants, MC

Status and phase

Completed

Phase 2

Phase 1

Conditions

Age-related Macular Degeneration

Treatments

Drug: Ranibizumab 0.5mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02140151

ML29258

Details and patient eligibility

About

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).

Full description

This is a multicenter, prospectively randomized, masked and controlled, interventional investigator sponsored phase I/II study of subjects with high-risk nonexudative age-related macular degeneration (AMD) treated with intravitreal ranibizumab quarterly for prophylaxis of conversion to exudative age-related macular degeneration.

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.

Enrollment

108 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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 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