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Completed

NCT Number: NCT00284050

Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement

This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.

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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

Novartis

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diabetic macular edema with center involvement in at least one eye
  • Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
  • Laser photocoagulation in the study eye can be withheld for at least 3 months after randomization

Exclusion criteria

  • Patients with uncontrolled systemic or ocular diseases
  • Have any history of any intraocular surgery in the study eye within the past 6 months preceding screening
  • Conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids

Other protocol-defined inclusion/exclusion criteria applied to the study.

Treatment and study plan

Ranibizumab 0.3 mg

Drug

6 mg/ml ranibizumab solution for intravitreal injection

Ranibizumab 0.5 mg

Drug

10 mg/ml ranibizumab solution for intravitreal injection

Sham injection

Drug

Non-treatment control for sham intravitreal injection.

Primary outcomes

  1. Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12

    Time frame: Baseline through the end of study (Month 12)

    Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.

  2. Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12

    Time frame: Baseline through the end of study (Month 12)

    Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.

Secondary outcomes

  1. Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12

    Time frame: Baseline through the end of study (Month 12)

    Optical Coherence Tomography (OCT) was assessed on both eyes at every study visit. These assessments were performed by trained personnel at the sites. OCT imaging was performed using the Zeiss Humphrey System Model 2000 (or later) with version A6.1 software running under Windows 95 or Windows 98. The analysis of the OCT images were performed by the Photographic Reading Center which provided a study manual and training materials. OCT operators, systems and software were certified prior to any evaluation of study patients.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Randomized, Double-masked, Multi-center, Phase II Study Assessing the Safety and Efficacy of Two Concentrations of Ranibizumab (Intravitreal Injections) Compared With Non-treatment Control for the Treatment of Diabetic Macular Edema With Center Involvement

Acronym: RESOLVE

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 31, 2006
Registry last updated
Feb 24, 2011

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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