Clinical trial NCT02734407: Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema
Official title: Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema in Subjects Who Completed the Three Year VISTA-DME Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Clinically Significant Diabetic Macular Edema
Lead sponsor: Retina-Vitreous Associates Medical Group
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean number of intravitreal aflibercept injections in 52 weeks
timeFrame: 12 months
measure: Proportion of subjects receiving 0 aflibercept injections in 52 weeks
timeFrame: 12 months
measure: Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks
timeFrame: 12 months
measure: Safety of ongoing aflibercept intravitreal injections as assessed by the incidence and severity of ocular and systemic adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Vision Change
timeFrame: 12 months
measure: Vision loss
timeFrame: 12 months
measure: Change in central retinal thickness
timeFrame: 12 months
measure: Development of clinically relevant diabetic macular edema
timeFrame: 12 months
measure: Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging)
timeFrame: 12 months
measure: Role of focal laser treatment in management of DME (Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment)
timeFrame: 12 months
measure: Ocular and systemic adverse events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Retina-Vitreous Associates Medical Group
name: David Boyer, MD
role: PRINCIPAL_INVESTIGATOR
References: