Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rocky Mountain Retina Consultants
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

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