Study for Recalcitrant Age Related Macular Degeneration

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

50 Patients with recalcitrant exudative age-related macular degeneration with a history of retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg and subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of ranibizumab.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David M. Brown, M.D.
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Age > 50 years

• Choroidal neovascularization secondary to AMD

• History of treatment with 0.5mg ranibizumab followed by 2.0mg ranibizumab for AMD

• Best corrected visual acuity in the study eye between 20/20 to 20/400 using an ETDRS chart

Exclusion Criteria:

• 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.

• Participation in another simultaneous medical investigation or trial

• Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline

• Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments.

• Presence of significant subfoveal fibrosis or atrophy.

• Prior treatment with intravitreal aflibercept injection

• Prior treatment with triamcinolone in the study eye within 6 months of BSL.

• Prior treatment with dexamethasone in the study eye within 30 days prior to BSL

• Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline

• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye

• Active intraocular inflammation (grade trace or above) in the study eye

• Current vitreous hemorrhage in the study eye

• History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye

• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

• Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)

• History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.

• History of allergy to fluorescein, ICG or iodine, not amenable to treatment

• History of retinal pigment epithelial tear or rip