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 2 Trial)

Diabetic Macular Edema Clinical 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 2 Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368756
• Other study ID #: Endurance 2
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2014
• Last updated: April 3, 2018
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Palmetto Retina Center, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Endurance 2 Trial is to determine the need for ongoing intravitreal aflibercept injections for patients with diabetic macular edema who have previously completed the VISTA study.

Description:

The Endurance 2 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-DME). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Aflibercept
A 2mg dose of intravitreal Aflibercept given as needed with possible laser until end of protocol.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Palmetto Retina Center, LLC	Regeneron Pharmaceuticals, Retina Consultants Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Measurement of the Need for Ongoing Intravitreal Aflibercept Injections in the Management of DME	Measured by: Mean number of injections in 52 weeks.; Proportion of subjects receiving 0 injections in 52 weeks.	12 months
Secondary	Composite Measurement of Longer-term Efficacy of Intravitreal Aflibercept Injections in the Management of DME	By evaluating: Mean change in visual acuity from baseline to week 52; Proportion of subjects with gain or loss of 0 to 5 letters from baseline to week 52; Mean change in central retinal thickness from baseline to week 52; Percentage of subjects with no CR-DME (as defined in the protocol) on SD-OCT from baseline to week 52; Proportion of subjects with stable, worsened, or improved diabetic retinopathy; Incidence and severity of ocular and systemic adverse events	12 months
Secondary	Measurement of Longer-term Safety of Intravitreal Aflibercept Injections in the Management of DME: Incidence and severity of ocular and systemic adverse events	By evaluating: *Incidence and severity of ocular and systemic adverse events	12 months
Secondary	Composite Measurement of the Role of Focal Laser Treatment in Decreasing the Treatment Burden Among Subjects Who Require Ongoing Aflibercept Treatment in the Management of DME	Measured by: Proportion of subjects that receive focal laser treatment (FLT); Mean number of intravitreal aflibercept injections before and after receiving FLT; Mean change in visual acuity from baseline to week 52; Mean change in central retinal thickness from baseline to week 52; Incidence and severity of ocular and systemic adverse events	12 months
Secondary	Composite Evaluation of the Role of (ultrawide-field, if available) Baseline vs 52-Week Fluorescein Angiography-determined Retina Ischemia in Predicting Past and Future Anti-VEGF Treatment Burden, Anatomic and Visual Outcomes.	Measured by: Mean number of injections in 52 weeks based on quantification of ischemic areas; Mean change in visual acuity from baseline to week 52 based on quantification of ischemic areas; Mean change in central retinal thickness from baseline to week 52 based on quantification of ischemic areas	12 months