The Endurance 1 Trial

NCT02297204 | Completed Phase 4

• 1 other identifier: REG-2014-11-006
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Need for ongoing intravitreal aflibercept injections in the management of DME

  To assess the need for ongoing intravitreal aflibercept injections for subjects who were enrolled and completed the 3-year VISTA DME (VGFT-OD-1009) trial and to characterize long-term efficacy and safety of aflibercept intravitreal injections in the management of DME by evaluating mean number of injections in 52 weeks and proportion of subjects receiving 0 (zero) injections in 52 weeks.

  12 months

Secondary Outcomes (7)

• Vision change

  12 months

• Vision loss

  12 months

• Change in central retinal thickness

  12 months

• Development of clinically relevant diabetic macular edema

  12 months

• 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

Study Arms (1)

aflibercept

EXPERIMENTAL

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.

Procedure: Focal Laser Treatment; Drug: aflibercept 2.0 mg

Interventions

Focal Laser Treatment 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.

Also known as: FLT

aflibercept

aflibercept 2.0 mg DRUG

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

Also known as: Eylea

aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
• Pregnant or breast-feeding women
• 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.

Sponsors & Collaborators

• Northern California Retina Vitreous Associates: lead
• Regeneron Pharmaceuticals: collaborator

MeSH Terms

Interventions

aflibercept

Study Officials

• Rahul Khurana, MD

  Northern California Retina Vitreous Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 21, 2014
• Study Start: November 1, 2014
• Primary Completion: December 13, 2017
• Study Completion: March 19, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-02