The purpose of this study is to evaluate if microplasmin is safe and effective when injected into the vitreous without performing a vitrectomy.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of patients with a total posterior vitreous detachment induced 14
days post-injection.
Secondary outcome
- Proportion of patients with total posterior vitreous detachment
- Macular Edema resolution
- Change in Best Corrected Visual Activity (the abillity to see letters on a
chart in front and to the side of the patient without moving the eyes).
- Achievement and time to improve the Best Corrected Visual Activity
- Maintenance of gain in vision
- Moderate/sustained/severe visual lost and time to obtain visual lost
- VFQ-25 questionnaire
- Need for alternative therapy
- Progression of severity of diabetic retinopathy
Background summary
The vitreous is an approximately spherical transparent gel like structure that
is attached in the back of the eye to the retina (the light sensitive part of
the eye responsible for vision). Certain eye diseases, like diabetic
retinopathy, may be associated with the vitreous pulling on the retina. This
can result in problems with vision and other complications. An option for
treatment is a specific type of eye surgery called a vitrectomy (surgery to
loosen and remove the vitreous from the retina. However this surgery can be
difficult and there may be complications that limit its usefulness and/or
outcome.
Microplasmin is an experimental drug that will be tested to evaluate if its
injection in the vitreous will induce a total posterior vitreous detachment,
loosening the connection between the vitreous and the retina. Detachment of the
vitreous from the retina may improve certain retinal conditions, such as
diabetic retinopathy or diabetic macular edema.
Study objective
The purpose of this study is to evaluate if microplasmin is safe and effective
when injected into the vitreous without performing a vitrectomy.
Study design
This trial will investigate 3 doses of microplasmin: 25, 75 and 125 µg, in 3
successive groups of patients. The patients in each group will be randomized to
active treatment or sham-injection.
Intervention
Injection with microplasmin in the vitreous of the study eye.
Study burden and risks
After the injection patients need to return to the hospital for a number of 10
follow-up examinations. During these visits patients receive a full eye
examination.
The risks associated to the injection are low, and potential complications can
be treated effectively by antibiotics or a vitrectomy.
14 Bridgecourt Office Park, Walkinstown Ave.
Dublin 12
Ireland
14 Bridgecourt Office Park, Walkinstown Ave.
Dublin 12
Ireland
Listed location countries
Age
Inclusion criteria
• Male or female patients aged >= 18;
• Patients with DME (Diabetic Macular Edema) involving the center of the macula with a macular thickness (in the central subfield on OCT (Ocular Coherence Tomography) of greater than 275 microns in the study eye;
• No evidence in study eye of complete macular PVD (Posterior Vitreous Detachment) (on biomicroscopy, B-scan or OCT), i.e. attached posterior hyaloid or incomplete PVD with vitreomacular adhesions;
• BCVA (Best Corrected Visual Activity) of 20/32 or worse in study eye;
• BCVA of 20/400 or better in the contralateral eye;
• Written informed consent obtained from the patient prior to inclusion in the study.
Exclusion criteria
• Evidence of fibrocellular proliferation characterized by whitish epimacular tissue (surface wrinkling is not an exclusion criterion) in the study eye;
• Evidence of foveal ischemia (foveal avascular zone: longest diameter > 1,000 microns) or dense, hard exudates beneath the fovea;
• Evidence of complete macular PVD in study eye on biomicroscopy, B-scan or OCT prior to planned study drug injection;
• Any evidence of proliferative retinopathy meeting the definition for PDR (Proliferative Diabetic Retinopathy) in the study eye;
• 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;
• 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.
• Patients with high myopia (axial length > 26.0 mm on A-scan ultrasound) or aphakia in the study eye;
• Patients with history of rhegmatogenous retinal detachment in the fellow eye;
• Patients who are considered likely to require intraocular surgery in either eye for any reason in the coming three months;
• Patients who have had ocular surgery in the study eye in the prior three months;
• Patients who have had a vitrectomy in study eye at any time;
• 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;
• Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months;
• Intravitreal injection of any drug in the study eye in the previous 3 months
• Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the Investigator;
• Patients who in the investigators view will not complete all visits and investigations, including the last double-masked visit at 6 months;
• Patients who have participated in an investigational drug study within the past 30 days;
• Patients with poor glycemic control according to the Investigator;
• Patients with hypertension (either Systolic Blood Pressure > 170 or Diastolic Blood Pressure > 100 mm Hg);
• Patients with a life expectancy less than 6 months;
• Patients who have previously participated in this trial.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-004626-93-NL |
| CCMO | NL14389.078.06 |