Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema

PHASE4CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

September 27, 2017

Study Completion Date

September 27, 2017

Conditions
Clinically Significant Diabetic Macular Edema
Interventions
PROCEDURE

Assigned Intervention

All subjects receiving PRN IVT aflibercept injections will be evaluated for focal laser treatment beginning at week 12 through the end of the study as assigned intervention. If the subject meets any of the criteria for focal laser treatment (FLT), fluorescein angiography (FA) will be performed to guide the focal laser treatment. Focal laser treatment and focal laser re-treatment will be administered no more than once every 90 days.

DRUG

aflibercept 2.0 mg

If a subject has recurrent CR-DME they will receive an IVT aflibercept injection

All Listed Sponsors
lead

Retina-Vitreous Associates Medical Group

OTHER

NCT02734407 - Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema | Biotech Hunter | Biotech Hunter