sing an anti inflammatory eye implant (Ozurdex) to help improve surgical outcomes in patients with scar tissue (PVR) on the retina

Phase 1

• Conditions: Proliferative Vitreoretinopathy; MedDRA version: 14.0 Level: PT Classification code 10038934 Term: Retinopathy proliferative System Organ Class: 10015919 - Eye disorders; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2011-004498-96-GB
• Lead Sponsor: Moorfields Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-07
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified