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Retina

Title: A Multicenter, Randomized, Placebo-Controlled, Double-Masked, Parallel-Group, Dose-Ranging Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy: The MIVI III (Microplasmin For Vitreous Injection III) Trial

PI: Brooks W. McCuen, II , MD

CRC: Greg Anderson, PAC

Synopsis:

The main objective of this Phase IIb drug trial is to evaluate the safety and efficacy of several doses of intravitreal microplasmin in comparison to placebo when administered 7 days prior to pars plana vitrectomy for treatment of non-proliferative vitreoretinal disease to facilitate the creation of a total posterior vitreous detachment (PVD). This clinical drug trial will involve eligibility evaluation, enrollment, randomization, treatment by study drug or placebo, surgical vitrectomy, and six-month follow-up of patients with non-proliferative vitreoretinal disease without evidence of PVD over the macula in whom vitrectomy is indicated by Investigator evaluation. There will be approximately 12 sites with 120 patients (30/arm). Data analysis will be done by statistical methodology for hypothesis testing as well as descriptive statistics. It will include primary and secondary efficacy analyses. Safety assessments will include preoperative PVD evaluation along with intraoperative surgical parameters and post-injection/postoperative complications.

Eligibility Criteria:

Inclusion Criteria:

Male or female patients aged > 18 years
- with nonproliferative vitreoretinal disease without evidence of a complete macular PVD in the study eye on biomicroscopy, optical coherence tomography (OCT), or B-scan
- who are suitable candidates for conventional 2-port or 3-port pars plana vitrectomy
BCVA 20/400 or better in the non-study eye.
Be willing and able to provide informed consent prior to undergoing any study-related procedures.

Exclusion Criteria:

Evidence of complete macular PVD on biomicroscopy, OCT, or B-scan prior to planned study drug injection.
Patients with vitreous hemorrhage that 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 or proliferative vitreoretinopathy(PVR). Thorough retinal examination with scleral depression 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 non-study eye.
Patients who are considered likely to require intraocular surgery in the study eye for any reason other than the planned vitrectomy in the coming 3 months.
Patients who have had ocular surgery in the study eye in the prior 3 months.
Patients who have had a vitrectomy in the study eye at any time.
Patients with glaucoma that is not controlled with topical medication or that is associated with severe visual field loss.
Intravitreal injection of any drug or laser photocoagulation in the study eye in the previous 30 days.
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 Investigator’s view will not complete all visits and investigations.
Patients who have participated in an investigational drug study within the past 30 days.
Patients with a life expectancy less than 6 months.
Patients who have previously participated in this trial.