Clinical trial NCT02297204: The Endurance 1 Trial
Official title: Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Macular Edema in Subjects Who Completed the Three Year VISTA-DME Trial (The Endurance 1 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Lead sponsor: Northern California Retina Vitreous Associates
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2014-11-21
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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) end-point. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on the presence of CR-DME (Clinically Relevant-Diabetic Macular Edema). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days.

Detailed description: The safety and tolerability of intravitreal aflibercept injections have been investigated in previous Phase I, I/II and III studies in AMD, RVO, and DME trials. Potential safety issues associated with the route of administration or the pharmacology of aflibercept in the study population include decreased BCVA, intraocular inflammation, intraocular infection, transient and/or sustained elevation of intraocular pressure (IOP), cataract development or progression, retinal or intravitreal hemorrhage, macular edema, retinal break or detachment, and arterial thromboembolic events (ATEs). Safety will be assessed by visual acuity, ophthalmic examinations, fluorescein angiograms, OCT, intraocular pressure, vital signs, and adverse event documentation.

To minimize the risks of intraocular infections, all injections will be performed employing sterile techniques as described in Appendix A. Study drug administration will be held for subjects who experience certain ocular events or infections. In the event any subject develops an adverse event in the study eye that is considered by the evaluating physician to be severe in intensity, serious consideration should be given to withdrawing the subject from the study.

The PI or designated Sub-Investigators will review all adverse events on an ongoing basis to determine causality and relationship to study drug and/or study procedures.

Eligibility criteria: Inclusion Criteria:

1. Enrolled and Completed VISTA DME (VGFT-OD-1009) clinical trial
2. Willing and able to comply with clinic visits and study-related procedures
3. Provide signed informed consent
4. Enrollment in the trial within 12 weeks of trial activation.

Exclusion Criteria:

1. Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
2. Pregnant or breast-feeding women
3. Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

   * Contraception is not required for men with documented vasectomy. \*\*Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Primary outcomes:
measure: Need for ongoing intravitreal aflibercept injections in the management of DME
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: 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: 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: Ocular and systemic adverse events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Northern California Retina Vitreous Associates
name: Rahul Khurana, MD
role: PRINCIPAL_INVESTIGATOR
References: