Clinical trial NCT00123279: Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy
Official title: A Dose-escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitreomacular Traction Maculopathy
Eye Diseases
Keywords: diabetic macular edema
macular hole
vitreomacular traction syndrome
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2005-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the safety and preliminary efficacy of different doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy.

Detailed description: Study drug will be administered in the mid-vitreous by injection. Patients will be enrolled into the cohorts in a sequential dose/time-escalating fashion. To ensure that enrolment is evenly balanced across eligible conditions, enrolment of any specific underlying disease type into any cohort will be capped at five (5) patients.

Eligibility criteria: Inclusion Criteria:

* Patients with vitreomacular traction maculopathy for whom vitrectomy is indicated, according to the principal investigator, including:

  * Macular edema associated with vitreomacular traction (DME, VMTS);
  * Stage II-III macular hole of \< 6 months duration since symptom onset;
  * Demonstration of vitreomacular adhesion (based on preoperative optic coherence tomography \[OCT\]) in the study eye;
  * 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.

Exclusion Criteria:

* Evidence of fibrocellular proliferation characterized by whitish epimacular tissue (surface wrinkling is not an exclusion criterion).
* 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, proliferative vitreoretinopathy (PVR), or retinal degenerative changes in the study eye.
* Patients with high myopia or aphakia in the study eye
* Patients with history of rhegmatogenous retinal detachment in the fellow eye or family history of retinal detachment
* 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.
* 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 a history of uveitis or significant trauma in the study eye.
* Patients who are currently being treated for glaucoma 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 6 months or during the study.
* Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the investigator.
* Patients who, in the investigator's view, will not complete all visits and investigations, including the exit visit at 6 months.
* Patients who have participated in an investigational drug study within the past 30 days.
* HgA1c \> 9%.
* Patients with hypertension (either systolic blood pressure \[SBP\] \> 170 or diastolic blood pressure \[DBP\] \> 100 mm Hg).
* Patients with a life-expectancy less than 6 months.
* Patients who have previously participated in this trial.

Primary outcomes:
measure: Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction
timeFrame: Baseline, 1,2 and 3hr, 1, 3, 14, 28, 90 and 180 Days
Secondary outcomes:
measure: The occurrence of any (serious) adverse event
timeFrame: Throught-out the study
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, University of Amsterdam
city: Rotterdam
country: Netherlands
facility: Oogziekenhuis Rotterdam
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Marc deSmet, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: