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Completed

NCT Number: NCT00440609

Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema

The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and 2.0mg Ranibizumab.

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Key information

Conditions

Clinically Significant Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Long Island Vitreoretinal Consultants, Great Neck, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type I or Type II diabetic subjects
  • Vision between 20/20 and 20/400
  • Presence of Clinically Significant Diabetic Macular Edema

Exclusion criteria

  • Presence of any condition that would prevent clear visualization of the back of the eye
  • Uncontrolled glaucoma
  • Complications of glaucoma
  • Inflammation inside the eye
  • Certain prior eye surgeries, other than cataract surgery
  • Other eye diseases that may compromise the vision in the study eye
  • Certain prior eye treatments
  • Pregnancy
  • Uncontrolled health conditions
  • History of heart attack
  • History of stroke
  • Current participation in another investigational trial

Treatment and study plan

ranibizumab

Drug

0.5mg or 1.0mg intravitreal injection given monthly for 3 months then every other month if needed, for the first year.Patients may be treated monthly as needed. Patients in Cohort 1(the first 30 patients)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 24. Patients in Cohort 2(the remaining 20)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 12.Patients may receive 2.0mg ranibizumab for a period limited to 24 months following administration of the first 2.0mg dose. Patients completing 36 months will be eligible to be followed for an additional 24 months. Starting at Month 36, patients will be able to receive monthly, the assigned dose that they received/or could have received(if re-treatment criteria was met)at Month 35. 2/1/12 - the 2.0mg dose has been discontinued, all subjects will transition to the 0.5mg dose.

Primary outcomes

  1. To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema

    Time frame: month 12

  2. To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab

    Time frame: month 12

Secondary outcomes

  1. Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm.

    Time frame: month 12, 24, 36, 48 and 60

  2. Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm

    Time frame: month 12, 24, 36,48 and 60

  3. Changes observed on the fluorescein angiogram in each arm

    Time frame: Month 60

  4. Mean number of ranibizumab injections required in each arm

    Time frame: Month 60

  5. The need for "rescue therapy" with laser in each arm

    Time frame: Month 60

  6. Evaluate the efficacy and safety of ranibizumab in the fellow eye in the sub-group of patients who require treatment for clinically significant diabetic macular edema in the fellow eye

    Time frame: Month 60

Sponsors and collaborators

Lead sponsor

Philip J. ferrone, M.D.

Other

Registry information

Official study title

A Phase I/II Study Comparing the Treatment of Clinically Significant Diabetic Macular Edema (CSDME) With 0.5mg Ranibizumab, 1.0mg Ranibizumab and 2.0mg Ranibizumab

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 27, 2007
Registry last updated
Aug 2, 2013

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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