Clinically Significant Diabetic Macular Edema
Conditions
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.
Interventions
PROCEDUREAssigned 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.
If a subject has recurrent CR-DME they will receive an IVT aflibercept injection
Sponsors
Retina-Vitreous Associates Medical Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean number of intravitreal aflibercept injections in 52 weeks | 12 months |
| Proportion of subjects receiving 0 aflibercept injections in 52 weeks | 12 months |
| Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks | 12 months |
| Safety of ongoing aflibercept intravitreal injections as assessed by the incidence and severity of ocular and systemic adverse events | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging) | 12 months | Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging |
| Vision Change | 12 months | Mean change in visual acuity from baseline to week 52 |
| Ocular and systemic adverse events | 12 months | Incidence and severity of ocular and systemic adverse events as identified by eye examinations, imaging, and subject reporting |
| 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) | 12 months | Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment |
| Vision loss | 12 months | Proportion of subjects with gain or loss of 0 to 5 letters from baseline to week 52 |
| Change in central retinal thickness | 12 months | Mean change in central retinal thickness from baseline to week 52 |
| Development of clinically relevant diabetic macular edema | 12 months | Percentage of subjects with no clinically relevant diabetic macular edema seen on SD-OCT from baseline to week 52 |
Outcome results
None listed