Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration

Study Overview
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Brief Summary
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To evaluate Ranibizumab as prophylaxis against the conversion to neovascular Age-Related Macular Degeneration

Detailed Description
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This is an open-label, prospective, randomized study of intravitreally administered ranibizumab 0.5 mg in subjects with unilateral neovascular AMD in which the fellow (study) eye is at high-risk for also developing conversion to neovascular AMD. The Study will determine the efficacy of a quarterly injection of Ranibizumab to prevent the conversion of dry age-related macular degeneration to neovascular AMD in high risk eyes.

Official Title
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Prospective Double-blind Randomized Study to Evaluate Lucentis for Prophylaxis Against the Conversion to Neovascular Age-related Macular Degeneration (AMD) in High-risk Eyes (Let's ProTECT AMD Eyes)

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab 0.5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 50 years old Able to sign informed consent and comply with the study protocol for the duration of the two years. Nonexudative age-related macular degeneration (AMD) in one eye (study eye) •At time of enrollment, fellow non-study eye must have recently diagnosed (not more than 2 years prior to enrollment), angiographically documented, previously untreated prior to diagnosis, CNV lesion (i.e., leakage on fluorescein angiography AND subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration. Exclusion Criteria: Previous treatment with verteporfin PDT, Macugen®, Lucentis®, intravitreal Avastin®, intravitreal Eylea®, thermal laser, external beam radiation or other AMD therapy in the study eye. History of macular hole in study eye. History of vitrectomy in study eye. Lens extraction or implantation within the last 3 months. Capsulotomy within the last 1 month. Lens or other media opacity that would preclude good fundus photography or angiography within the next 2 years. Nevus > 2 disc areas within 3000 microns of the foveal center or with fluid or leakage on fluorescein angiography. Macular edema or signs of diabetic retinopathy more severe than 10 red dots (microaneurysms or blot hemorrhages). Retinal changes related to high myopia and no myopic correction greater than 8.00 diopters spherical equivalent [sphere + ½ cylinder]. Any progressive ocular disease that would affect visual acuity within the next 2 years. Previous participation in any studies of investigational drugs likely to have ocular effects within 30 days preceding the initial study treatment. Concurrent use of systemic anti-VEGF agents. Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye. For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia. Uncontrolled glaucoma in the study eye (defined as intraocular pressure > 25 mmHg) despite treatment with antiglaucoma medication). Patients who are unable to be photographed to document CNV due to known allergy to fluorescein dye, lack of venous access or cataract obscuring the CNV. Patients with other ocular diseases that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy. Current treatment for active systemic infection. Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders. History of recurrent significant infections or bacterial infections. Inability to comply with study or follow-up procedures. Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Participation in another simultaneous medical investigation or trial

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br>No treatment. Observation only | |
| Active Comparator: Quarterly Ranibizumab 0.5<br>Quarterly intravitreal injection of 0.5mg Ranibizumab Intervention: Drug: Ranibizumab 0.5mg | Drug: Ranibizumab 0.5mg<br> <br> * Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to neovascular AMD. (CNV leakage on FA and evidence of any fluid on SD-OCT) | The development of CNV will be assessed by CNV leakage on FA and evidence of any fluid on SD-OCT. | 2 years |