DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact

Diabetic Macular Edema Clinical Trial

— DA VINCI  

Official title:

A Double-Masked, Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema (DME)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789477
• Other study ID #: VGFT-OD-0706
• Status: Completed
• Phase: Phase 2
• First received: November 7, 2008
• Last updated: August 28, 2014
• Start date: December 2008
• Est. completion date: September 2010

Study information

• Verified date: August 2014
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaAustria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

Description:

Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: September 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with clinically significant DME with central involvement

• Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema

• ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye

Exclusion Criteria:

• History of vitreoretinal surgery in the study eye

• Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening

• Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening

• Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening

• Uncontrolled diabetes mellitus

• Uncontrolled hypertension defined as systolic > 180mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen

• Ocular disorders in the study eye, other than DME, that may confound interpretation of study results

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Procedure:
• Laser Photocoagulation
laser every 16 weeks as needed

Drug:
• Intravitreal Aflibercept Injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Bayer

Countries where clinical trial is conducted

United States,  Austria,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit.; Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).	At week 24	No
Secondary	Change in BCVA From Baseline to Week 52 - LOCF	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).	At week 52	No
Secondary	Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF	Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).	At week 24 and week 52	No
Secondary	Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF	Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).	At week 24 and week 52	No
Secondary	Number of Focal Laser Treatments		Week 1 to week 48	No