Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Proliferative Vitreoretinopathy

Treatments: Drug: placebo; Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU

Study type: Interventional

Funder types: Other

Identifiers

NCT00370760

8404

Details and patient eligibility

About

To evaluate the efficacy of oral colchicine combined with intraoperative infusion of dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of established proliferative vitreoretinopathy (PVR)

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cases with rhegmatogenous retinal detachment complicated by PVR grade C

Exclusion criteria

• History of pars plana vitrectomy for PVR grade C
• History of silicone oil injection
• History of ocular trauma
• Diabetic retinopathy
• Glaucoma
• Giant retinal tear

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU

2

Placebo Comparator group

Treatment:

Drug: placebo