Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial

NCT02299336 | Completed Phase 4 Results FDA Drug

• 1 other identifier: The Endurance 1 Trial
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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; NCT01363440) end-point. 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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial

  Measured by evaluating mean number of injections required for subjects who were enrolled and completed the 3-year VISTA DME (VGFT-OD-1009) trial

  Week 104

Secondary Outcomes (12)

• Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104

  Week 52, Week 104

• Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application.

  Before First Focal Laser Treatment (FLT) at Week 12 or later; After First FLT at up to 104 weeks

• Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104

  Week 52, Week 104

• Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104.

  Week 52, Week 104

• Number of Subjects With no Clinically-relevant Diabetic Macular Edema (as Defined in the Protocol) on Spectral Domain Optical Coherence Tomography From Baseline to Week 52 and Baseline to Week 104.

  Week 52, Week 104

Study Arms (1)

PRN (pro re nata)

OTHER

2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks

Drug: Aflibercept; Procedure: Focal Laser

Interventions

Aflibercept DRUG

pro re nata (PRN)

Also known as: Eylea

PRN (pro re nata)

Focal Laser PROCEDURE

Focal laser administered based on pre-specified criteria

PRN (pro re nata)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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:

• A subject who meets any of the following criteria will be excluded from the study:
• 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

• Greater Houston Retina Research: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (3)

Retina Consultants of Houston/The Medical Center

Houston, Texas, 77030, United States

Location

Retina Consultants of Houston/Katy office

Katy, Texas, 77494, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Related Publications (14)

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• Grover D, Li TJ, Chong CC. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD005656. doi: 10.1002/14651858.CD005656.pub2.

  PMID: 18254088 BACKGROUND

• Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. Ophthalmology. 1984 Dec;91(12):1464-74. doi: 10.1016/s0161-6420(84)34102-1.

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• Saaddine JB, Honeycutt AA, Narayan KM, Zhang X, Klein R, Boyle JP. Projection of diabetic retinopathy and other major eye diseases among people with diabetes mellitus: United States, 2005-2050. Arch Ophthalmol. 2008 Dec;126(12):1740-7. doi: 10.1001/archopht.126.12.1740.

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• Diabetic Retinopathy Clinical Research Network; Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, Edwards AR, Ferris FL 3rd, Friedman SM, Glassman AR, Miller KM, Scott IU, Stockdale CR, Sun JK. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35. doi: 10.1016/j.ophtha.2010.02.031. Epub 2010 Apr 28.

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  PMID: 20699456 BACKGROUND

• Wykoff CC, Ou WC, Khurana RN, Brown DM, Lloyd Clark W, Boyer DS; ENDURANCE Study Group. Long-term outcomes with as-needed aflibercept in diabetic macular oedema: 2-year outcomes of the ENDURANCE extension study. Br J Ophthalmol. 2018 May;102(5):631-636. doi: 10.1136/bjophthalmol-2017-310941. Epub 2017 Aug 16.

  PMID: 28814412 DERIVED

MeSH Terms

Interventions

aflibercept

Limitations and Caveats

Limitations of the ENDURANCE study include the small population and employment of aflibercept re-treatment criteria that allowed physicians to use their varying clinical judgement in determining anti-VEGF re-treatment instead of a strict protocol.

Results Point of Contact

• Title: Dr. Charles C. Wykoff
• Organization: Retina Consultants of Houston

ccwmd@houstonretina.com

7135243434

Study Officials

• Charles C Wykoff, MD

  Greater Houston Retina Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: November 24, 2014
• Study Start: November 24, 2014
• Primary Completion: January 9, 2017
• Study Completion: January 9, 2017
• Last Updated: June 4, 2019
• Results First Posted: June 7, 2018

Record last verified: 2019-05

Locations

US (3)