Status:
COMPLETED
Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema
Lead Sponsor:
Rocky Mountain Retina Consultants
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Diabetic Retinopathy
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
Diabetic macular edema (DME) results from abnormal leakage of macromolecules into the extracellular space from microaneurysms and incompetent blood vessel walls due to small vessel damage from high bl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00387582
Start Date
July 1 2006
End Date
February 1 2009
Last Update
May 6 2014
Active Locations (1)
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1
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States, 84107