EUCTR2014-004778-41-GR
Active, not recruiting
Not Applicable
Assessment of Anatomical and Functional Outcomes in Subjects Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA) - Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
ConditionsVitreomacular Traction/ Vitreomacular AdhesionMedDRA version: 18.0Level: LLTClassification code 10070236Term: Vitreomacular adhesionSystem Organ Class: 100000004853MedDRA version: 18.0Level: LLTClassification code 10051065Term: Vitreomacular traction syndromeSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsJetrea
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vitreomacular Traction/ Vitreomacular Adhesion
- Sponsor
- Alcon Research, Ltd.
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Ages Eligible for study: 18 years and older
- •2\. Diagnosed with VMT/sVMA, with evidence of focal VMT visible on Spectral Domain – Optical Coherence Tomography (SD\-OCT)
- •3\. Read, signed, and date an Institutional Review board/Ethics Committeeapproved informed consent form
- •4\. Willing and able to attend all study visits
- •5\. Other protocol\-specified inclusion criteria may apply
- •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 70
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\. Women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
- •2\. Hypersensitivity to ocriplasmin or any of the JETREA excipients
- •3\. Active or suspected intraocular or periocular infection in either eye
- •4\. Participation in any interventional clinical trial within 30 days prior to baseline
- •5\. Presence of epiretinal membrane (ERM) over the central macula in the study eye
- •6\. Broad VMT/sVMA \> 1500 microns in the study eye
- •7\. History of vitrectomy in the study eye
- •8\. History of laser photocoagulation to the macula in the study eye
- •9\. Any relevant concomitant ocular condition in the study eye that, in the opinion of the Investigator, could be expected to worsen or require surgical intervention during the study period
- •10\. Macular hole of \> 400 microns diameter in the study eye
Outcomes
Primary Outcomes
Not specified
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Completed
Phase 4
Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)Vitreomacular traction10047060NL-OMON40974Alcon Laboratories50