Diabetic macular edema MedDRA version: 8.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema
Conditions
Sponsors
ThromboGenics N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I. Male or female patients aged > or = 18 II. Patients with DME involving the center of the macula with a macular thickness (in the central subfield on OCT) of greater than 275 microns in the study eye III. No evidence in study eye of complete macular PVD (on biomicroscopy, B-scan or OCT), i.e. attached posterior hyaloid or incomplete PVD with vitreomacular adhesions IV. BCVA of 20/32 or worse in study eye V. BCVA of 20/400 or better in the contralateral eye VI. Written informed consent obtained from the patient prior to inclusion in the study 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: I. Evidence of fibrocellular proliferation characterized by whitish epimacular tissue (surface wrinkling is not an exclusion criterion) in the study eye II. Evidence of foveal ischemia (foveal avascular zone: longest diameter > 1,000 microns) or dense, hard exudates beneath the fovea III. Evidence of complete macular PVD in study eye on biomicroscopy, B-scan or OCT prior to planned study drug injection IV. Any evidence of proliferative retinopathy meeting the definition for PDR in the study eye V. Patients with vitreous hemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye VI. Patients with rhegmatogenous retinal detachment, PVR, or retinal degenerative changes associated with increased risk of retinal detachment in the study eye. Such retinal degenerative changes include lattice degeneration or cystic retinal tufts. Thorough retinal examination should be performed in all patients to rule out these changes. VII. Patients with high myopia (axial length > 26.0 mm on A-scan ultrasound) or aphakia in the study eye VIII. Patients with history of rhegmatogenous retinal detachment in the fellow eye IX. Patients who are considered likely to require intraocular surgery in either eye for any reason in the next three months X. Patients who have had ocular surgery in the study eye in the prior three months XI. Patients who have had a vitrectomy in the study eye at any time. XII. Patients with glaucoma that is not controlled with topical medication or that is associated with severe visual field loss documented by perimetry in the study eye XIII. Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months XIV. Intravitreal injection of any drug in the study eye in the previous 3 months XV. Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the Investigator XVI. Patients who in the investigators view will not complete all visits and investigations, including the last double-masked visit at 6 months XVII. Patients who have participated in an investigational drug study within the past 30 days XVIII. Patients with poor glycemic control according to the Investigator XIX. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg) XX. Patients with a life expectancy less than 6 months XXI. Patients who have previously participated in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and preliminary efficacy of several doses of intravitreal microplasmin in patients with diabetic macular edema.;Secondary Objective: None;Primary end point(s): EFFICACY EVALUATIONS/CRITERIA Primary efficacy endpoint: • Proportion of patients with total PVD (i.e. vitreous detachment to the equator) as determined by masked, Central Reading Center evaluation at day 14 visit imaging (4-quadrant US and OCT) (Central Reading Center representative: Prof. Dr. M. Ulbig, Munich, Germany) Secondary efficacy endpoint: • Proportion of patients with total PVD as determined by masked, Central Reading Center evaluation of imaging (4-quadrant US and OCT) from study visits other than the day 14 post-injection visit • ME resolution (change from baseline in macular thickness in the central subfield; central foveal thickness [mean thickness at the point of intersection of the 6 radial scans]; and macular volume on OCT) • Change in BCVA • Achievement of >= 2 and >= 3 lines improvement in BCVA without need for alternative therapy (i.e. intravitreal drug injection, laser photocoagulation, or vitrectomy) and time to >= 2 and >= 3 lines improvement in BCVA without need for alternative therapy • Maintenance or gain in vision (no change in number of letters or a gain of one or more letters from baseline) • Moderate visual loss (decrease from baseline of >= 15 letters, i.e. 3 lines), sustained moderate visual loss (moderate visual loss at each of two consecutive visits 3 or more months apart) and severe visual loss (decrease from baseline of >= 30 letters, i.e. 6 lines) and time to moderate, sustained moderate and severe visual loss • VFQ-25 • Need for alternative therapy (either intravitreal drug administration, laser photocoagulation, or vitrectomy) • Progression of DR severity (Masked Central Reading Center): >= 2 step progression; >= 3 step-progression; time to >= 2 step progression; time to >= 3 step-progression All of the above secondary endpo | — |
Countries
Belgium, Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed