Patients with exudative AMD with focal vitreomacular adhesion MedDRA version: 9.1 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina MedDRA version: 9.1 Level: LLT Classification code 10051065 Term: Vitreomacular traction syndrome MedDRA version: 9.1 Level: PT Classification code 10060823 Term: Choroidal neovascularisation
Conditions
Sponsors
ThromboGenics NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female patients aged > 50 -Presence of focal vitreomacular adhesion with a central retinal thickness of at least 250 µm as measured by OCT. -Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component. -The total area of CNV (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area -The total lesion area must be =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Evidence of complete macular PVD in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection -Patients with vitreous haemorrhage 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 angiography in the study eye or other opacities precluding visualisation of the fundus. -Patients with history of rhegmatogenous retinal detachment or PVR in the study eye -Patients with high myopia (> 8D) or aphakia in the study eye -Patients who have had ocular surgery in the study eye in the prior three months -Patients who have had a vitrectomy in the study eye at any time. -Patients with uncontrolled glaucoma in the study eye (defined as intraocular pressure > 26 mm Hg in spite of treatment with anti-glaucoma medication) -Intravitreal injection of any drug or photodynamic therapy in the study eye in the previous 10 days or such planned treatment in the 10 days following study drug injection -Patients who are pregnant or of child-bearing potential not utilizing an acceptable form of contraception. Acceptable methods of birth control include intrauterine device, oral, implanted, or injected contraceptives, and barrier methods with spermicide. -Patients who, in the investigators view, will not complete all visits and investigations -Patients who have participated in an investigational drug study within the past 30 days -Patients who have previously participated in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and preliminary efficacy of intravitreal microplasmin in patients with exudative AMD with focal vitreomacular adhesion ;Secondary Objective: ;Primary end point(s): Safety Endpoint: -History/full ophthalmologic examination (including dilated biomicroscopy, ophthalmoscopy, OCT): baseline, post-injection days 7, 14 and 28 and post-injection months 3, 6 and 12. -Fundus Photography: baseline, day 28 and 12 months post-injection -Fluorescein angiography: baseline, day 28 and 12 months post-injection Efficacy Primary endpoint -Proportion of patients with release of focal vitreomacular adhesion by day 28 as determined by masked Central Reading Center evaluation of imaging (OCT) Efficacy Secondary endpoint: -Vitreomacular adhesion status and PVD status at visits other than day 28 post-injection visit (OCT and ultrasound) -Visual Acuity (ETDRS) -Central retinal/lesion thickness (OCT) -Membrane growth: evaluated by OCT (spectral domain where available) and fluorescein-angiography -Size of fluorescein leakage -Number of patients requiring additional therapy -Number of injections of anti-VEGF required -Initial fluid-free interval and anti-VEGF free interval -Time to 4th anti-VEGF injection -VFQ-25 | — |
Countries
Belgium, France, Germany, Italy, United Kingdom
Outcome results
None listed