EUCTR2011-004498-96-GB
Active, not recruiting
Phase 1
Ozurdex in proliferative vitreoretinopathy; a randomised control trial - Ozurdex in PVR
ConditionsProliferative VitreoretinopathyMedDRA version: 14.0 Level: PT Classification code 10038934 Term: Retinopathy proliferative System Organ Class: 10015919 - Eye disordersTherapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]
DrugsOzurdex
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Proliferative Vitreoretinopathy
- Sponsor
- Moorfields Eye Hospital
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. All patients with established PVR (grade C) following rhegmatogenous retinal detachment requiring surgery.
- •2\. Ability to give informed consent
- •3\. Willingness to accept randomization and attend follow\-up.
- •4\. Patients must be over 18 and under 80 years of age.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 120
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 20
Exclusion Criteria
- •1\. Individuals less than 18 years old and older than 80 years old
- •2\. Penetrating intraocular trauma
- •3\. Uncontrolled glaucoma or uveitis
- •4\. Previous steroid induced glaucoma
- •5\. Proliferative Diabetic Retinopathy
- •6\. Pregnant or Breastfeeding females
- •7\. Previous known adverse reaction to the IMP
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Ozurdex Treatment for macular edema associated with retinitis pigmentosaDiseases of the eye and adnexaKCT0002497Seoul National University Hospital17
Completed
Not Applicable
Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein OcclusionMacular EdemaRetinal Vein OcclusionNCT01618266Allergan375
Recruiting
Not Applicable
Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 MonthsEndophthalmitisNCT06268561Centre Hospitalier Universitaire de Saint Etienne8
Completed
Not Applicable
Anatomic Outcomes Following Ozurdex InjectionsRetinal Vein OcclusionsNCT01282411Barnes Retina Institute10
Completed
Phase 2
Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic RetinopathyProliferative Diabetic RetinopathyNCT01478737Anders Kvanta100