Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2013-005464-25-ES
EUCTR2013-005464-25-ES
Active, not recruiting
Not Applicable

Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA) - Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion

Alcon Research, Ltd.0 sites474 target enrollmentFebruary 25, 2014
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsVitreomacular Traction/ Symptomatic Vitreomacular AdhesionMedDRA version: 16.1Level: LLTClassification code 10070236Term: Vitreomacular adhesionSystem Organ Class: 100000004853MedDRA version: 16.1Level: 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/ Symptomatic Vitreomacular Adhesion
Sponsor
Alcon Research, Ltd.
Enrollment
474
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 25, 2014
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Ages Eligible for Study: 18 Years and older.
  • •\- Genders Eligible for Study: Both.
  • •\- Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMT visible on Spectral Domain Optical
  • •Coherence Tomography (SD\-OCT).
  • •\- Read, sign, and date an Institutional Review Board/Ethics Committee\-approved informed consent form.
  • •\- Other protocol\-defined 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 142

Exclusion Criteria

  • •\- Women of childbearing potential if pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
  • •\- Hypersensitivity to ocriplasmin or any of the Jetrea excipients.
  • •\- Active or suspected intraocular or periocular infection.
  • •\- Presence of Epiretinal Membrane (ERM) over the macula at baseline.
  • •\- Broad VMT/VMA \>1500 microns at Baseline.
  • •\- History of vitrectomy in the study eye.
  • •\- History of laser photocoagulation to the macula in the study eye
  • •\- Any relevant concomitant ocular condition that, in the opinion of the investigator, could be expected to worsen or require surgical intervention during the study period
  • •\- Macular hole of \>400?m diameter in the study eye
  • •\- High myopia in study eye

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesio
EUCTR2013-005464-25-NLAlcon Research, Ltd.474
Active, not recruiting
Not Applicable
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular AdhesioVitreomacular Traction/ Symptomatic 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]
EUCTR2013-005464-25-FRAlcon Research, Ltd.474
Active, not recruiting
Not Applicable
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular AdhesioVitreomacular Traction/ Symptomatic Vitreomacular AdhesionMedDRA version: 17.0Level: LLTClassification code 10070236Term: Vitreomacular adhesionSystem Organ Class: 100000004853MedDRA version: 17.0Level: LLTClassification code 10051065Term: Vitreomacular traction syndromeSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
EUCTR2013-005464-25-PLAlcon Research, Ltd.474
Completed
Phase 4
Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)Vitreomacular traction10047060
NL-OMON40974Alcon Laboratories50
Active, not recruiting
Not Applicable
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular AdhesioVitreomacular Traction/ Symptomatic Vitreomacular AdhesionMedDRA version: 16.1Level: LLTClassification code 10070236Term: Vitreomacular adhesionSystem Organ Class: 100000004853MedDRA version: 16.1Level: LLTClassification code 10051065Term: Vitreomacular traction syndromeSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
EUCTR2013-005464-25-ITAlcon Research Ltd474