Clinical trial NCT02140151: Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration
Official title: Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration (AMD) in Vulnerable Eyes With Nonexudative AMD Trial: A Multicenter, Prospectively Randomized, Masked and Controlled, Interventional Investigator Sponsored Phase I/II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Age-related Macular Degeneration
Keywords: amd
non-exudative macular degeneration
exudative macular degeneration
age-related macular degeneration
ranibizumab
anti-VEGF
Lead sponsor: Southern California Desert Retina Consultants, MC
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 108
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of exudative AMD
timeFrame: 2 years
Secondary outcomes:
measure: Vision change
timeFrame: 2 years
measure: Vision loss
timeFrame: 2 years
measure: Number of injections
timeFrame: 2 years
measure: Baseline predictive factors
timeFrame: 2 years
measure: Development of geographic atrophy (GA)
timeFrame: 2 years
measure: Ocular adverse events
timeFrame: 2 years
measure: Systemic adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Palm Desert
country: United States
facility: Southern California Desert Retina Consultants
state: California
city: Baltimore
country: United States
facility: Elman Retina
state: Maryland
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
Study officials:
affiliation: Southern California Desert Retina Consultants
name: Maziar Lalezary, MD
role: PRINCIPAL_INVESTIGATOR
References: