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OpenTrials
Completed

NCT Number: NCT01297569

Ranibizumab "Treat and Extend" in Diabetic Macular Edma

This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.

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Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Oslo, 0264, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Visual impairment due to focal or diffuse macular edema with center involvement
  • Diabetes type 1 or 2, HbA1c < 12.0%
  • CRT = or > 250 μm

Exclusion criteria

  • Active inflammation or infection
  • Uncontrolled glaucoma
  • Iris neovascularization, active proliferative retinopathy or vitreomacular traction
  • Prior laser photocoagulation according to defined timelines
  • History of stroke, uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

ranibizumab

Drug

Primary outcomes

  1. Change in Best Corrected Visual Acuity(BCVA)

    Time frame: from month 0 (baseline) to month 12

Secondary outcomes

  1. change in central retinal thickness (CRT)

    Time frame: from month 0 to month 12

  2. the number of injections needed

    Time frame: 12 months

  3. the number of patients with improvement in BCVA from baseline

    Time frame: 12 months

  4. the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized "Treat and Extend" Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema

Acronym: OPTIMAL

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 16, 2011
Registry last updated
Feb 23, 2017

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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