A Dose-Escalation Clinical Trial of Intravitreal Microplasmin in Patients undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy. - MIVI

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

INCLUSION CRITERIA

i. Male or female patients aged 18 to 80 years inclusive.
ii. Patients with vitreomacular traction maculopathy for whom vitrectomy is
indicated according to the principal investigator, including:
o Macular edema associated with vitreomacular traction (DME, VMTS)
o Stage II-III macular hole of < 6 months duration since symptom onset
iii Demonstration of vitreomacular adhesion (based on preoperative OCT) in the
study eye
o OCT - presence of posterior hyaloid membrane inserting on to the macula, but
with some area of clear separation visible between the retina and the posterior
hyaloid
iv 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).
ii. 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.
iii. Patients with rhegmatogenous retinal detachment, PVR, or retinal degenerative
changes in the study eye.
iv. Patients with high myopia or aphakia in the study eye
v. Patients with history of,rhegmatogenous retinal detachment in the fellow eye or
family history of retinal detachment
vi. Patients who are considered likely to require intraocular surgery in the study eye
for any reason other than vitreomacular traction maculopathy/macular edema in
the coming three months.
vii. Patients who have had ocular surgery in the study eye in the prior three months.
viii. Patients who have had a vitrectomy in the study eye at any time.
ix. Patients with a history of uveitis or significant trauma in the study eye.
x. Patients who are currently being treated for glaucoma in the study eye.
xi. Patients who have had laser photocoagulation treatment in the study eye in the
previous 3 months.
xii. Intravitreal injection of any drug in the study eye in the previous 6 months or
during the study.
xiii. Patients who are pregnant or of child-bearing potential not utilizing a form of
contraception acceptable to the Investigator.
xiv. Patients who in the investigators view will not complete all visits and
investigations, including the exit visit at 6 months.
xv. Patients who have participated in an investigational drug study within the past
30 days.
xvi. HgA1c > 9%.
xvii. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg).
xviii. Patients with a life-expectancy less than 6 months.
xix. Patients who have previously participated in this trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials