Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration
To evaluate Ranibizumab as prophylaxis against the conversion to neovascular Age-Related Macular Degeneration
Study Start Date
Estimated Completion Date
- Drug: Ranibizumab 0.5mg
- Drug: Ranibizumab 0.5mg
- Ophthalmology: Clinical Pharmacology,Retina
- Physician Assistant: Clinical Pharmacology,Ophthalmology
- Macular Degeneration
NJ Retina (Retina Associates of New Jersey) -- ML29346
Phase 1/Phase 2
NJ Retina (Retina Associates of New Jersey)
- 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.
- 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
50 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (2)
|NJ Retina Retina Associates of New Jersey - Teaneck, New Jersey||45.7 miles||Kerri Intonatofirstname.lastname@example.org|
|NJ Retina Retina Associates of New Jersey - Vauxhall, New Jersey||64.2 miles||Kerri Intonatoemail@example.com|