Diabetic Macular Edema (diabetic eye disease)

• Conditions: Diabetic Macular Edema (DME), is the most common cause of visual impairment in patients with diabetic retinopathy (DR). It is the accumulation of extracellular fluid in the retinal tissues of the macula and is a microvascular complication of diabetes. In this study patients will have macular edema that meets the Early Treatment Diabetic Retinopathy Study (ETDRS) criteria for clinically significant macular edema (CSME), (but patients with imminently vision threatening macular edema are excluded).; MedDRA version: 14.0Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2005-000900-15-DK
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-17
• Last Update Posted: 15 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

- Have type 1 or type 2 diabetes mellitus as defined by American Diabetes Association (ADA) and World Health Organization (WHO) criteria.
- Have DME (based on 7-field stereoscopic fundus photogrpahs confirmed by the Fundus Photograph Reading Center) at Visit 1, showing in the study eye:
[A] Any photographically detectable retinal thickening at or between 100 and 500 microns from the center of the macula.
or
[B] Retinal thickening >= 1 disc area in size, any part of which is within 100 microns from the center of the macula,
or
[C] Both [A] and [B].
BUT EXCLUDING
Retinal thickening, or hard exudates associated with adjacent retinal thickening, less than 100 microns from the center of the macula, as noted on stereo fundus photographs.
- Have, in the study eye, a DR level corresponding to ETDRS retinopathy score >=35b and <=53e, as determined by 7-field stereoscopic fundus photographs as confirmed by the Fundus Photograph Reading Center.
- Have, in the study eye, a best-corrected visual acuity of at least 75 letters on the ETDRS visual acuity chart.
- Male or female, aged 18 years or older at Visit 1.
- Have and HbA1c value <=11.0% at Visit 1.
- Have seated BP<= 160/90 mmHg, as determined by the mean of three separate resting measurements at Visit 1. Patients with a BP above this limit may be re-screened 1 month later.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 155
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 155

Exclusion Criteria

- Retinal thickening, or hard exudates associated with adjacent retinal thickening, less than 100 microns from the center of the macula, noted on stereo fundus photographs in the study eye at Visit 1.
- Have had previous photocoagulation for DR and/or DME in the study eye prior to Visit 1.
- Are likely to require focal/grid or pan-retinal (scatter) photocoagulation in the study eye within 3 months of study randomization, in the opinion of the investigator, at Visit 1.
- Have tractional DME, thickened taut posterior hyaloid membrane, or cystoid changes in the study eye, in the opinion of the investigator, as determined by OCT.
- Have had intra-ocular surgery, e.g. cataract extraction, within 6 months of visit 1, and/or anticipated intra-ocular surgery during the study, in the opinion of the investigator, in the study eye.
- Have an occludable anterior chamber angle or open angle glaucoma in the study eye, in the opinion of the investigator, at Visit 1. Ocular hypertension in the absence of a glaucomatous visual field defect is not an exclusion criterion.
- Have current vitreous or pre-retinal hemorrhage in the study eye at Visit 1.
- Have eccentric or imperfect fixation in the study eye at Visit 1.
- Have a history of conditions in the study eye at Visit 1 which, in the opinion of the investigator, might affect macular edema, alter visual acuity, or confound stereoscopic fundus photography or OCT readings, including but not limited to: intra-ocular surgery, significant chorioretinal scars, optic atrophy, retinal degeneration, retinal vein occlusion, retinal artery occlusion, rubeosis iridis, pathologic myopia, age-related macular degeneration, posterior uveitis, branch vein or artery occlusion.
- Are unable to provide adequate OCT readings or fundus photography at Visit 1 ( as assessed by the reading center) for reasons including but not limited to: media opacity or compliance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified