Study for Recalcitrant Age Related Macular Degeneration
Completed · Phase 4
Conditions studied: Age Related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT01543568
- Run by
- David M. Brown, M.D.
- People needed
- 46
- Starts
- 2012-02-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2017-01-02
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Retina Consultants of Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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