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OpenTrials
Completed

NCT Number: NCT02366468

Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema

The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Diseases Sensation Disorders Signs and Symptoms Vascular Diseases Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Ahaus, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%
  • Patients with visual impairment due to DME in at least one eye
  • BCVA ≥ 24 and ≤ 78 letters in the study eye

Exclusion criteria

  • Active intraocular inflammation
  • Any active infection in either eye at the
  • Structural damage within 0.5 disc diameter of the center of the macula in the study eye
  • Uncontrolled glaucoma in either eye at screening

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Ranibizumab 0.5 mg

Drug

intravitreal injection

Other names: Lucentis

Primary outcomes

  1. Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)

    Time frame: Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

    BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity

Secondary outcomes

  1. Number of Visits

    Time frame: Baseline to Month 12

    Mean number of visits during the study

  2. Number of Injections

    Time frame: Baseline to Month 12

    mean number of injections in the study eye during the study

  3. Number of Treatment Free Intervals

    Time frame: Baseline to Month 12

    A treatment-free interval is the interval between the first NO treatment given when the reason for NO treatment given is one of the three stability criteria and the first subsequent YES treatment given after that.

  4. Mean Change in Central Subfield Retinal Thickness (CSRT)

    Time frame: Baseline to Month 12

    Evaluated by central reading center assessing OCT images

  5. Mean Change of Foveal Center Point Thickness

    Time frame: Baseline to Month 12

    Evaluated by central reading center assessing OCT images

  6. Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale

    Time frame: Baseline to Month 12

    Evaluated by central reading center scoring fundus photography

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 12-months, Randomized, VA-assessor Blinded, Multicenter, Controlled Phase IV Trial to Investigate Noninferiority of Two Treatment Algorithms (Discretion of the Investigator vs. Pro re Nata) of 0.5 mg Ranibizumab in Patients With Visual Impairment Due to Diabetic Macula Edema

Acronym: DIVERSE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 19, 2015
Registry last updated
Jan 4, 2019

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

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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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