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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00370760
• Collaborator: (none)
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Proliferative Vitreoretinopathy	Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
Placebo Comparator: 2	Drug: placebo

Outcome Measures

Primary Outcome Measures

1. Retinal reattachment rate []

Secondary Outcome Measures

1. PVR recurrence, []

2. macular pucker, []

3. reoperation, []

4. ocular hypotony, []

5. visual acuity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamid Ahmadieh, MD	Tehran		Iran, Islamic Republic of	16666

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

• Principal Investigator: Hamid Ahmadieh, MD, Ophthalmic Research Center of Shaheed Beheshti Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00370760
• Other Study ID Numbers: 8404
• First Posted: Sep 1, 2006
• Last Update Posted: Jun 26, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: PVR; Oral colchicine; Dexamethasone; low molecular weight heparin; 5-FU
• Additional relevant MeSH terms: Vitreoretinopathy, Proliferative; Dexamethasone; Colchicine; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin

Study Results

No Results Posted as of Jun 26, 2008