Status:
COMPLETED
Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration
Lead Sponsor:
Leonard Feiner, MD, PhD
Collaborating Sponsors:
NJ Retina (Retina Associates of New Jersey)
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate Ranibizumab as prophylaxis against the conversion to neovascular Age-Related Macular Degeneration
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02302989
Start Date
May 1 2015
End Date
July 1 2018
Last Update
August 28 2018
Active Locations (2)
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1
NJ Retina (Retina Associates of New Jersey)
Teaneck, New Jersey, United States, 07666
2
NJ Retina (Retina Associates of New Jersey)
Vauxhall, New Jersey, United States, 07088