Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00387582
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : May 6, 2014
Genentech, Inc.
Information provided by (Responsible Party):
Roy A. Goodart, M.D., Rocky Mountain Retina Consultants

Brief Summary:
This study will evaluate the clinical efficacy of intra-vitreal injections of Ranibizumab (Lucentis) in the treatment of Diabetic Macular Edema as compared to grid/focal laser.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Diabetic Macular Edema Drug: Ranibizumab (Lucentis) Procedure: Argon Laser Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lucentis in the Treatment of Macular Edema - A Phase II, Single Center, Randomized Study to Evaluate the Efficacy of Ranibizumab Versus Focal Laser Treatment in Subjects With Diabetic Macular Edema
Study Start Date : July 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: I
Lucentis injections for the first three months of the study and then per the protocol for the duration of the trial.
Drug: Ranibizumab (Lucentis)
Lucentis 0.5 mg monthly for the first three months and then per protocol for the duration of the trial.
Other Name: NDC # 50242-0080-01, Brand Name is Lucentis
Active Comparator: II
Argon Laser treatment at enrollment and then per the protocol for the duration of the study.
Procedure: Argon Laser
Argon laser at entry to trial and then per protocol for the duration of the study.

Primary Outcome Measures :
  1. Prevention of vision loss at one year as evidenced by ETDRS visual acuity. [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures :
  1. Reduction in retinal thickening based on Optical Coherence Tomography. [ Time Frame: 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects will be eligible if the following criteria are met:

    • Clinically significant diabetic macular edema (CSME) or clinically significant diabetic macular edema with center involvement (CSME-CI) as defined by the ETDRS Trial (ETDRS Research Group 1987 and 1991)
    • Retinal thickening within 500 mm of the center of the fovea
    • Hard exudates within 500 mm of the center of the fovea (if associated with adjacent retinal thickening, which may be outside of 500um limit)
    • An area of macular edema greater than 1 disc area but within 1 disc diameter of the center of the macula
    • Ability to provide written informed consent and comply with study assessments for the full duration of the study
    • Age > 21 years
    • Visual acuity < 20/320 with definite retinal thickening due to diabetic macular edema based on clinical exam
    • Retinal thickness on OCT measuring 250 microns or more in the central subfield or 350 microns of more in any non-central subfield
    • Media clarity and pupillary dilatation, patient cooperation, and adequate fundus photographs and OCT will be obtainable
    • No other ocular conditions that could cause macular edema will be present

Exclusion Criteria:

  • Subjects who meet any of the following criteria will be excluded from this study:

    • Other causes of macular edema will be present
    • Intraocular pressures exceed 25 mm Hg
    • Prior enrollment in the study
    • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
    • Participation in another simultaneous medical investigation or trial or previous trial of Lucentis or Avastin
    • Premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
    • Pregnancy or lactation (evidenced by Early Pregnancy Test (EPT) over the counter test)
    • Current treatment of a systemic infection
    • Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
    • History of recurrent significant infections or bacterial infections
    • Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either

      • Require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or
      • If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period
    • Active intraocular inflammation (grade trace or above) in the study eye
    • Current vitreous hemorrhage in the study eye
    • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
    • History of idiopathic or autoimmune-associated uveitis in either eye
    • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
    • Concurrent ocular disease associated with choroidal neovascularization to include but not limited to presumed ocular Histoplasmosis, high myopia, or macular degeneration
    • Prior/Concomitant Treatment
    • Patient will not have had panretinal photocoagulation treatment within 4 months
    • Grid/focal laser within 2 months of randomization
    • Subtenon steroid in study eye within 6 months
    • Treatment with systemic steroid currently or within the last 4 weeks
    • IVTA within 3 months
    • Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
    • Prior participation in a Genentech ranibizumab clinical trial
    • Previous treatment with intravitreally (in either eye) or intravenously administered Avastin (bevacizumab)
    • Concurrent use of systemic anti-VEGF agents
    • Previous use of Macugen in study eye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00387582

United States, Utah
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Rocky Mountain Retina Consultants
Genentech, Inc.
Principal Investigator: Roy A. Goodart, MD Rocky Mountain Retina Consultants

Responsible Party: Roy A. Goodart, M.D., Principal Investigator, Rocky Mountain Retina Consultants Identifier: NCT00387582     History of Changes
Other Study ID Numbers: FVF3799S
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Roy A. Goodart, M.D., Rocky Mountain Retina Consultants:
Macular Edema
Diabetic Retinopathy

Additional relevant MeSH terms:
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents