University Hospital Leuven
Leuven, Belgium
NCT Number: NCT01055535
This study will evaluate the safety and efficacy of Microplasmin administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal microplasmin may offer physicians a safe agent for pharmacologic vitreolysis and induction of Posterior Vitreous Detachment (PVD) without the need for vitrectomy. This clinical study is justified because the study sponsor believes the potential benefits outweigh the potential risks, as outlined below.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Leuven, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
VI. Patients with history of rhegmatogenous retinal detachment in the fellow eye 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 glaucoma that is not controlled with topical medication or that is associated with severe visual field loss, documented by perimetry, in the study eye X. Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months XI. Intravitreal injection of any drug in the study eye in the previous 3 months XII. Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the Investigator XIII. Patients who, in the investigators view, will not complete all visits and investigations, including the last visit at 6 months after the last injection XIV. Patients who have participated in an investigational drug study within the past 30 days XV. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg) XVI. Patients with a life expectancy less than 6 months XVII. Patients who have previously participated in this trial
125 µg intravitreal injection
Time frame: baseline, day 7, 14 and 28 and months 3 and 6
Time frame: Day 28
ThromboGenics
Industry
An Open Label, Single Centre Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion
Acronym: MIVI-8
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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