Intravitreal Alflibercept Injection (IAI) for Persistent Diabetic Macular Edema (DME) After Treatment With Bevacizumab And Ranibizumab
Overview
- Phase
- Phase 4
- Intervention
- Alflibercept
- Conditions
- Diabetic Macular Edema
- Sponsor
- Southeast Retina Center, Georgia
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Reduction in Macular Edema
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly Intravitreal Aflibercept (IAI) doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled.
Detailed Description
This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled. Starting at week 24, patients may be eligible to receive additional 2mg IAI (2q4) treatment if both of the following criteria is met and the investigator feels additional treatment would be beneficial: * Loss of \>5 letters from baseline or best previously recorded best corrected visual acuity (BCVA) * Presence of new or recurrent intraretinal fluid or subretinal fluid as assessed by SD OCT Starting at week 24, rescue therapy with macular laser photocoagulation may be administered if any the following criteria are met * Loss of \> 15 letters from baseline or best previously recorded BCVA and loss of acuity felt to be secondary to Diabetic Macular Edema (DME) and not from other cause (i.e., cataract, epiretinal membrane, vitreous hemorrhage, etc) and investigator feels patient would benefit from rescue therapy * Increase in SD OCT CSF \> 100 um from baseline or best previously recorded SD OCT CSF and investigator feels patient would benefit from rescue therapy. Every 4 week visit will include ETDRS BCVA, IOP measurement, Slit lamp biomicroscopy, Indirect ophthalmoscopy, Heidelberg Spectralis SD-OCT and evaluation for systemic and ocular adverse events. Fundus Photography and Wide field Optos fluorescein angiography will be performed at baseline and at week 20and week 52. STUDY DURATION: Approximately 52 weeks to the end of the study. Primary endpoint will be evaluated at week 52.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A patient must meet the following criteria to be eligible for inclusion in the study:
- •Adults with Diabetes Mellitus
- •Documented history of ROTATE study completion (within 3 months +/- 1 week of exit visit)
- •BCVA ETDRS visual acuity letter score 20/25-20/400
- •Thickening due to DME involving the center of the macula evident on clinical exam
- •DME on OCT at baseline (\>305 microns if male or \>290 microns if female) as assessed on Heidelberg Spectralis SD OCT
- •At least 30 days but less than 45 days since prior 0.3 mg ranibizumab injection
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed HIPAA statement and informed consent prior to any study procedures
Exclusion Criteria
- •A patient who meets any of the following criteria will be excluded from the study:
- •Macular edema considered to be due to a cause other than DME (ERM, Vein Occlusion, Postop CME, uveitis)
- •History of PRP within 3 months prior to enrollment or anticipated need for PRP
- •History of idiopathic or autoimmune uveitis in the study eye
- •Cataract surgery in the study eye within 90 days of baseline
- •Any intraocular surgery within 90 days of baseline
- •Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect vision
- •Clinically significant pre-retinal fibrosis involving the macula in the study eye per investigator judgment
- •Intraocular inflammation of trace or above in the study eye
- •Evidence of active infection in either eye
Arms & Interventions
Open Label Single Arm Trial
Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab
Intervention: Alflibercept
Outcomes
Primary Outcomes
Reduction in Macular Edema
Time Frame: 52 weeks from baseline
Reduction in macular edema measured as * Proportion of eyes with baseline SD OCT CST \>350 um demonstrating \>15% reduction at week 52 from baseline * Proportion of eyes that demonstrate SD OCT CST \<305um (males) and \<290 um (females) at week 52 from baseline