Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C

Proliferative Vitreoretinopathy Clinical Trial

Official title:

Repeated Intra-silicone Oil Injection of Methotrexate for Management of Proliferative Vitreoretinopathy Grade C; A Multi-center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04482543
• Other study ID #: 23454
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2020
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Hamid Ahmadieh, MD
• Phone: +98 9122195871
• Email: hahmadieh[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multicenter randomized clinical trial evaluates the effect of multiple intra-silicone oil injections of methotrexate (MTX) on rhegmatogenous retinal detachment (RRD) with grade C proliferative vitreoretinopathy (PVR).

74 eyes with the diagnosis of RRD with PVR grade C will be randomized into two groups: the intervention group and the control group. All eyes undergo pars plana vitrectomy(PPV) and intraocular injection of silicone oil (SO). At the end of the surgical procedure, intra-SO injection of 250 µg MTX will be performed in the intervention group. No intra-SO injection will be done in the control group. In the intervention group, Intra-SO injection of MTX will be repeated at 3 and 6 weeks postoperatively. Silicone oil removal will be done 3 months after surgery.Spectral-domain optical coherence tomography (SD-OCT) image of the macula will be acquired at months 3 and 6. The retinal reattachment rate at months 6 will be assessed as the main outcome measure of the study. Best corrected visual acuity, retinal reproliferation rate and adverse events are the secondary outcome measures. Comprehensive ocular examination will be performed at weeks 1, 3, 6 and at months 3, 4 and 6.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: September 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Rhegmatogenous retinal detachment with proliferative vitreoretinopathy grade C

Exclusion Criteria:

• Age of under 18 years old

• Pregnancy

• Glaucoma

• Macular disorders

• Diabetic retinopathy

• Retinal vascular occlusion

• History of penetrating ocular trauma

• Giant retinal tear

• Chronic uveitis

• History of intraocular steroid injection

Related Conditions & MeSH terms

• Proliferative Vitreoretinopathy

Intervention

Drug:
• Methotrexate
Intra-silicone oil injection of 250 µg methotrexate is done at the end of surgery and is repeated at weeks 3 and 6 postoperatively.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal reattachment rate	Funduscopy	6 months
Secondary	Best corrected visual acuity	Snellen chart	6 months
Secondary	Retinal reproliferation rate	Funduscopy	6 months
Secondary	Adverse events	Slit-lamp, tonometry and funduscopy	6 months