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

Clinically Significant Diabetic Macular Edema Clinical Trial

— Endurance3  

Official title:

Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema in Subjects Who Completed the Three Year VISTA-DME Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734407
• Other study ID #: Endurance 3
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: September 27, 2017

Study information

• Verified date: March 2019
• Source: Retina-Vitreous Associates Medical Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The Endurance3 Trial is a Phase IV open label 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) upon the presence of CR-DME (Clinically Relevant DME) as noted by OCT (Optical Coherence Tomography) imaging and examination. In addition, subjects who meet the re-treatment criteria will be eligible for focal laser treatment every 90 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 27, 2017
• Est. primary completion date: September 27, 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 ment or women of childbearing potential who are unwilling to practice adequate contraception during the study

Related Conditions & MeSH terms

• Clinically Significant Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Procedure:
• Assigned Intervention
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.

Drug:
• aflibercept 2.0 mg
If a subject has recurrent CR-DME they will receive an IVT aflibercept injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Retina-Vitreous Associates Medical Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of intravitreal aflibercept injections in 52 weeks		12 months
Primary	Proportion of subjects receiving 0 aflibercept injections in 52 weeks		12 months
Primary	Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks		12 months
Primary	Safety of ongoing aflibercept intravitreal injections as assessed by the incidence and severity of ocular and systemic adverse events		12 months
Secondary	Vision Change	Mean change in visual acuity from baseline to week 52	12 months
Secondary	Vision loss	Proportion of subjects with gain or loss of 0 to 5 letters from baseline to week 52	12 months
Secondary	Change in central retinal thickness	Mean change in central retinal thickness from baseline to week 52	12 months
Secondary	Development of clinically relevant diabetic macular edema	Percentage of subjects with no clinically relevant diabetic macular edema seen on SD-OCT from baseline to week 52	12 months
Secondary	Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging)	Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging	12 months
Secondary	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)	Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment	12 months
Secondary	Ocular and systemic adverse events	Incidence and severity of ocular and systemic adverse events as identified by eye examinations, imaging, and subject reporting	12 months