Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema

NCT02734407 | Completed Phase 4

• 1 other identifier: Endurance 3
• 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) 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

Conditions

Clinically Significant Diabetic Macular Edema

Outcome Measures

Primary Outcomes (4)

• 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 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

• Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging)

  12 months

Study Arms (1)

Open-Label Arm

EXPERIMENTAL

2mg Aflibercept, 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: Assigned Intervention; Drug: aflibercept 2.0 mg

Interventions

Assigned Intervention 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 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.

Also known as: FLT

Open-Label Arm

aflibercept 2.0 mg DRUG

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

Also known as: Eylea, VEGF-Trap

Open-Label Arm

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:

• 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

Sponsors & Collaborators

• Retina-Vitreous Associates Medical Group: lead

MeSH Terms

Interventions

aflibercept

Study Officials

• David Boyer, MD

  Retina-Vitreous Associates Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: April 12, 2016
• Study Start: January 1, 2015
• Primary Completion: September 27, 2017
• Study Completion: September 27, 2017
• Last Updated: March 26, 2019

Record last verified: 2019-03