Two-week Retreatment Interval Study for Treated Age-related Macular Degeneration Refractory to Monthly Aflibercept
Status unconfirmed · Phase 4
Conditions studied: Neovascular Age-related Macular Degeneration
In brief
This study is designed to evaluate the safety and efficacy of every 2 week intravitreal aflibercept injections in a population of neovascular AMD patients that have demonstrated refractory subretinal fluid with or without intraretinal fluid despite prior monthly intravitreal aflibercept treatment.
Key facts
- Study ID
- NCT03468296
- Run by
- Tennessee Retina
- People needed
- 22
- Starts
- 2018-04-01
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2018-04-20
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 50 years
- A diagnosis of choroidal neovascularization related to age-related macular degeneration
- ETDRS refracted BCVA ≥ 20/200
- Prior treatment with any anti-VEGF agent for ≥ 12 months
- Prior treatment with at least five intravitreal aflibercept at the time of screening (week -2) with an average inter-treatment interval <35 days
- Presence of persistent subretinal fluid with or without intraretinal fluid on OCT at most recent standard of care visit occurring 28-35 days following most recent intravitreal aflibercept injection
- Demonstration of definite improvement in overall retinal thickness and/or subretinal fluid on OCT based on evaluation of examining investigator at screening visit (week -2) 13-15 days following most recent standard of care visit
- o Note: screening OCT will be performed prior to dilation to allow for undilated ETDRS BCVA testing following confirmation of eligibility
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
- Ocular Exclusion Criteria:
- Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g. advanced diabetic retinopathy, advanced glaucoma)
- Active intraocular inflammation (grade trace or above) in the study eye
- Current vitreous hemorrhage in the study eye
- History of macula-involving rhegmatogenous retinal detachment or macular hole (Stage 2 - 4) in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Aphakia in the study eye
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
- Systemic Exclusion Criteria
- Use of systemic anti-VEGF medications within 6 months of screening visit
- History of cerebrovascular accident, myocardial infarction, ventricular arrhythmia, unstable angina, coronary or peripheral artery bypass or stenting within 6 months of day 0
- History of deep vein thrombosis or pulmonary embolus within 6 months of day 0
- Uncontrolled hypertension (>160/100 on medical treatment)
Where it is running
- Tennessee Retina — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.