The Endurance 1 Trial

NCT ID: NCT02297204

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-03-19

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

aflibercept

2mg, as needed, intravitreal administration. All subjects will be treated with intravitreal (IVT) aflibercept injections as needed in the presence of clinically relevant diabetic macular edema (CR-DME). If CR-DME is not present the subject will not receive an IVT aflibercept injection and will be observed.

If a subject has recurrent CR-DME they will receive an IVT aflibercept 2.0 mg injection and interval between visits will be reduced to 4 weeks.

At week 12 through end of study, all subjects will be evaluated for focal laser treatment.

Group Type: EXPERIMENTAL

Focal Laser Treatment

Intervention Type: PROCEDURE

All subjects receiving PRN IVT aflibercept injections will be evaluated for focal laser treatment beginning at week 12 through the end of the study. 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 mg

Intervention Type: DRUG

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

Interventions

Focal Laser Treatment

All subjects receiving PRN IVT aflibercept injections will be evaluated for focal laser treatment beginning at week 12 through the end of the study. 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.

Intervention Type: PROCEDURE

aflibercept 2.0 mg

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

Intervention Type: DRUG

Other Intervention Names

FLT; Eylea

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Northern California Retina Vitreous Associates

OTHER

Sponsor Role: lead

Responsible Party

Rahul Khurana, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rahul Khurana, MD

Role: PRINCIPAL_INVESTIGATOR

Northern California Retina Vitreous Associates

Other Identifiers

REG-2014-11-006

Identifier Type: -

Identifier Source: org_study_id

NCT02368756

Identifier Type: -

Identifier Source: nct_alias