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Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Roy A. Goodart, M.D., Rocky Mountain Retina Consultants
ClinicalTrials.gov Identifier:
NCT00387582
First received: October 11, 2006
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Diabetic Retinopathy
Diabetic Macular Edema
Drug: Ranibizumab (Lucentis)
Procedure: Argon Laser
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rocky Mountain Retina Consultants:

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

Secondary Outcome Measures:
  • Reduction in retinal thickening based on Optical Coherence Tomography. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: July 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387582

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

No publications provided

Responsible Party: Roy A. Goodart, M.D., Principal Investigator, Rocky Mountain Retina Consultants
ClinicalTrials.gov Identifier: NCT00387582     History of Changes
Other Study ID Numbers: FVF3799S
Study First Received: October 11, 2006
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rocky Mountain Retina Consultants:
Diabetes
Macular Edema
Diabetic Retinopathy
Lucentis
Ranibizumab

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014