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Completed

NCT Number: NCT00789477

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

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vienna, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser Photocoagulation

Procedure

laser every 16 weeks as needed

Other names: macular laser therapy

Intravitreal aflibercept injection

Drug

Other names: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye

Primary outcomes

  1. Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)

    Time frame: At week 24

    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).

Secondary outcomes

  1. Change in BCVA From Baseline to Week 52 - LOCF

    Time frame: At week 52

    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).

  2. Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF

    Time frame: At week 24 and week 52

    Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

  3. Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF

    Time frame: At week 24 and week 52

    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).

  4. Number of Focal Laser Treatments

    Time frame: Week 1 to week 48

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Bayer

Registry information

Official study 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)

Acronym: DA VINCI

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Nov 11, 2008
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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