Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration

Phase 1

Completed

• Conditions: Age-related Macular Degeneration
• Interventions: Drug: Ranibizumab 0.5mg

• Registration Number: NCT02302989
• Lead Sponsor: Leonard Feiner, MD, PhD

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 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.

Study Timeline

• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Study Start: 2015-05
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quarterly Ranibizumab 0.5	Ranibizumab 0.5mg	Quarterly intravitreal injection of 0.5mg Ranibizumab Intervention: Drug: Ranibizumab 0.5mg

Primary Outcome Measures

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

Trial Locations

Locations (1)

NJ Retina (Retina Associates of New Jersey); 🇺🇸 Vauxhall, New Jersey, United States