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

Retina-Vitreous Associates Medical Group9 enrolled

Overview

The Endurance Trial is a Phase IV open label clinical study to assess the need for ongoing intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days

The Endurance3 Trial is a Phase IV open label study to assess the need for ongoing intravitreal aflibercept injections after the 3 year VISTA DME (VGFT-OD-1009) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) upon the presence of CR-DME (Clinically Relevant DME) as noted by OCT (Optical Coherence Tomography) imaging and examination. In addition, subjects who meet the re-treatment criteria will be eligible for focal laser treatment every 90 days.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clinically Significant Diabetic Macular Edema

Interventions

Assigned InterventionPROCEDURE

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.

aflibercept 2.0 mgDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Enrolled and completed VISTA DME (VGFT-OD-1009) clinical trial * Willing and able to comply with clinic visits and study-related procedures * Provide signed informed consent * Enrollment in the trial within 12 weeks of trial activation Exclusion Criteria: * Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline * Pregnant or breast-feeding women * Sexually active ment or women of childbearing potential who are unwilling to practice adequate contraception during the study

Outcomes

Primary Outcomes

Mean number of intravitreal aflibercept injections in 52 weeks

Time frame: 12 months

Proportion of subjects receiving 0 aflibercept injections in 52 weeks

Time frame: 12 months

Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks

Time frame: 12 months

Safety of ongoing aflibercept intravitreal injections as assessed by the incidence and severity of ocular and systemic adverse events

Time frame: 12 months

Secondary Outcomes

Vision Change

Mean change in visual acuity from baseline to week 52

Time frame: 12 months

Vision loss

Proportion of subjects with gain or loss of 0 to 5 letters from baseline to week 52

Time frame: 12 months

Change in central retinal thickness

Mean change in central retinal thickness from baseline to week 52

Time frame: 12 months

Development of clinically relevant diabetic macular edema

Percentage of subjects with no clinically relevant diabetic macular edema seen on SD-OCT from baseline to week 52

Time frame: 12 months

Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging)

Data from ClinicalTrials.gov

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