Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

Completed · Phase 2

Conditions studied: Diabetic Retinopathy, Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT00387582

Run by

Rocky Mountain Retina Consultants

People needed

49

Starts

2006-07-01

Expected to finish

2009-02-01

Last updated by the study team

2014-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rocky Mountain Retina Consultants — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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