A Phase I/II dose-finding study of intraocular mitomycin-c adjunct in vitrectomy for retinal detachment and proliferative vitreoretinopathy (MORPH-1)
Proliferative vitreoretinopathy in rhegmatogenous retinal detachment
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 route of administration and duration of treatment 3 minutes of application.
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
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 Zost