Proliferative vitreoretinopathy in rhegmatogenous retinal detachment Eye Diseases
Conditions
Interventions
Additional use of mitomycin-C during retinal detachment surgery (vitrectomy) including dose or dose range 0.1, 0.2, 0.3, 0.4, 0.5, and 1 mg/ml, dose frequency one dose per participant, intraocular rou
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 04/09/2025: 1. Individuals aged =18 years 2. Macula-OFF Rhegmatogenous Retinal Detachment (RRD) complicated with Proliferative vitreoretinopathy (PVR) grade C 3. Requiring surgery with silicone oil tamponade 4. Able and agree to provide written informed consent 5. Able and agree to attend all protocol-mandated follow-up visits 6. If participants of childbearing potential, must have a negative pregnancy test at screening visit and prior to surgery, and agree to at least one form of contraception throughout the duration of the trial Previous key inclusion criteria: 1. Individuals aged =18 years 2. Recurrent macula-OFF Rhegmatogenous Retinal Detachment (RRD) complicated with Proliferative vitreoretinopathy (PVR) grade C 3. Requiring surgery with silicone oil tamponade 4. Able and agree to provide written informed consent 5. Able and agree to attend all protocol-mandated follow-up visits 6. If participants of childbearing potential, must have a negative pregnancy test at screening visit and prior to surgery, and agree to at least one form of contraception throughout the duration of the trial
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 04/09/2025: 1. Previous known adverse reaction to Mitomycin C (MMC) 2. History of open globe Injury 3. Uncontrolled or advanced glaucoma (defined as uncontrolled eye pressure, changes to medication, recent surgery in the last 3 months or being considered for surgical treatment). 4. Uncontrolled or advanced glaucoma (defined as uncontrolled eye pressure, changes to medication, recent surgery in the last 3 months or being considered for surgical treatment) 5. Uncontrolled uveitis 6. Previous steroid-induced glaucoma 7. Proliferative diabetic retinopathy or vasculopathy 8. Participant who is pregnant or is planning to become pregnant for the duration of the trial 9. Participant who has given birth within the past 6 months or is breastfeeding 10. Suspected ocular/periocular infection (e.g. Herpes Simplex Virus, Varicella Zoster Virus, mycobacterial, fungal disease) 11. Aphakia 12. Participant in whom a lensectomy is planned at the time of surgery 13. Pre-existing anterior chamber intraocular lens 14. Participant enrolled in another interventional clinical trial within 90 days prior to screening 15. Participants receiving any other treatments, such as anti-cancer or autoimmune disease Previous key exclusion criteria: 1. Previous known adverse reaction to mitomycin C (MMC) 2. History of open globe injury 3. A diagnosis of ocular hypertension on two or more pressure-lowering medications 4. Uncontrolled or advanced glaucoma (defined as uncontrolled eye pressure, changes to medication, recent surgery in the last 3 months or being considered for surgical treatment) 5. Uncontrolled uveitis 6. Previous steroid-induced glaucoma 7. Proliferative diabetic retinopathy or vasculopathy 8. Participant who is pregnant or is planning to become pregnant for the duration of the trial 9. Participant who has given birth within the past 6 months or is breastfeeding 10. Suspected ocular/periocular infection (e.g. Herpes Simplex Virus, Varicella Zoster Virus, mycobacterial, fungal disease) 11. Aphakia 12. Participant in whom a lensectomy is planned at the time of surgery 13. Pre-existing anterior chamber intraocular lens 14. Participant enrolled in another interventional clinical trial within 90 days prior to screening 15. Participants receiving any other treatments, such as anti-cancer or autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 03/06/2026: Safety: The occurrence of Dose Limiting Events (DLEs) over 5 weeks post-surgery. Safety events are assessed against DLE criteria from Day 1 to week 5. Efficacy: Successful retinal re-attachment without tamponade at 6-month patient follow-up, as assessed by the slit-lamp examination. Previous primary outcomes: Safety: The occurrence of Dose Limiting Events (DLEs) over 7 days post-surgery. Safety events are assessed against DLE criteria from Day 1 to Day 7. Efficacy: Successful retinal re-attachment without tamponade at 6-month patient follow-up, as assessed by the slit-lamp examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in visual acuity (measured using ETDRS chart at 4 metres starting distance) in the MMC treatment group from baseline to the 6-month final follow-up visit Target: +10 ETDRS letters improvement Acceptable: +5 ETDRS letters improvement 2. PVR grade, change from baseline to the 6-month final follow-up visit Target: Complete absence of PVR in 80% of patients in the MMC group Acceptable: Significant difference in the rate of PVR presence between the MMC group and the wider population PVR grade C as measured/mapped on widefield fundus photography, OCT and clinical fundus examination 3. Reduction in flare measured by laser flare photometry, change from baseline to the 6-month final follow-up visit Target: mean 5-10 pc/ms reduction in flare post-surgery/MMC Acceptable: mean 0-5 pc/ms reduction in flare post-surgery/MMC | — |
Countries
United Kingdom
Contacts
Public ContactJessie Barry
Outcome results
None listed