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

Ozurdex in proliferative vitreoretinopathy; a randomised control trial - Ozurdex in PVR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004498-96-GB

Enrollment

140

Registered

2011-10-07

Start date

2011-11-25

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proliferative Vitreoretinopathy MedDRA version: 14.0 Level: PT Classification code 10038934 Term: Retinopathy proliferative System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: Ozurdex Product Name: Ozurdex Pharmaceutical Form: Implant INN or Proposed INN: Dexamethasone CAS Number: 50-02-2

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Does the use of an additional anti inflammatory agent (ozurdex) given at the time of surgery in patients with established PVR (scar tissue on the retina)result in an improved surgical outcome at 6 months after the surgery?; Secondary Objective: Does the use of an additional anti inflammatory agent (ozurdex) given at the time of surgery in patients with established PVR (scar tissue on the retina)have a positive effect on the following: 1. Visual acuity 6 and 12 months after initial surgery (number of letters read on a standardised vision chart) 2. macula oedema and thickness (the presence of abnormal waterlogging and therefore increased thickness of the most sensitive part of the retina) 3. the development of overt PVR recurrence (whether the scar tissue returns more floridly after surgery 4. complete retinal reattachment (the ability to re attach the entire retina as in some cases this is not possible) 5. stable posterior (post equatorial) retinal reattachment (the ability to reattach the central part of the retina,as in some cases the entire retina cannot be reattached) 6. tractional retinal detachment (the presence of any remaining scar tissue pulling the retina off after surge ;Primary end point(s): Stable retinal reattachment with removal of silicone oil without further vitreoretinal surgical intervention at 6 months;Timepoint(s) of evaluation of this end point: 6 months after initial surgery for proliferative vitreoretinopathy	—

Measure

Time frame

Main Objective: Does the use of an additional anti inflammatory agent (ozurdex) given at the time of surgery in patients with established PVR (scar tissue on the retina)result in an improved surgical outcome at 6 months after the surgery?; Secondary Objective: Does the use of an additional anti inflammatory agent (ozurdex) given at the time of surgery in patients with established PVR (scar tissue on the retina)have a positive effect on the following: 1. Visual acuity 6 and 12 months after initial surgery (number of letters read on a standardised vision chart) 2. macula oedema and thickness (the presence of abnormal waterlogging and therefore increased thickness of the most sensitive part of the retina) 3. the development of overt PVR recurrence (whether the scar tissue returns more floridly after surgery 4. complete retinal reattachment (the ability to re attach the entire retina as in some cases this is not possible) 5. stable posterior (post equatorial) retinal reattachment (the ability to reattach the central part of the retina,as in some cases the entire retina cannot be reattached) 6. tractional retinal detachment (the presence of any remaining scar tissue pulling the retina off after surge ;Primary end point(s): Stable retinal reattachment with removal of silicone oil without further vitreoretinal surgical intervention at 6 months;Timepoint(s) of evaluation of this end point: 6 months after initial surgery for proliferative vitreoretinopathy

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: All at 12 months post initial surgical intervention for PVR (with the exception of visual acuity, which will be measured at 6 and 12 months); Secondary end point(s): i) visual acuity (median and ETDRS of 55 letters or better) at 6 and 12 months post op ii) macula oedema and thickness (OCT analysis) iii) development of overt PVR recurrence iv) complete retinal reattachment v) stable posterior (post equatorial) retinal reattachment vi) tractional retinal detachment vii) hypotony/raised IOP viii) macula pucker/epiretinal membrane ix) cataract x) quality of life assessment	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: All at 12 months post initial surgical intervention for PVR (with the exception of visual acuity, which will be measured at 6 and 12 months); Secondary end point(s): i) visual acuity (median and ETDRS of 55 letters or better) at 6 and 12 months post op ii) macula oedema and thickness (OCT analysis) iii) development of overt PVR recurrence iv) complete retinal reattachment v) stable posterior (post equatorial) retinal reattachment vi) tractional retinal detachment vii) hypotony/raised IOP viii) macula pucker/epiretinal membrane ix) cataract x) quality of life assessment

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026