NCT04482543

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

July 18, 2020

Last Update Submit

July 18, 2020

Conditions

Proliferative Vitreoretinopathy

Outcome Measures

Primary Outcomes (1)

  • Retinal reattachment rate

    Funduscopy

    6 months

Secondary Outcomes (3)

  • Best corrected visual acuity

    6 months

  • Retinal reproliferation rate

    6 months

  • Adverse events

    6 months

Study Arms (2)

Intra-silicone oil injection of 250 µg methotrexate

ACTIVE COMPARATOR
Drug: Methotrexate

No intra-silicone oil injection of methotrexate

NO INTERVENTION

Interventions

MethotrexateDRUG

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

Intra-silicone oil injection of 250 µg methotrexate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rhegmatogenous retinal detachment with proliferative vitreoretinopathy grade C

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

RECRUITING

Related Publications (1)

  • Nourinia R, Safi S, Mohammadpour M, Riazi-Esfahani H, Ansari Astaneh MR, Falavarjani KG, Ramezani A, Karimi S, Fekri S, Ebrahimiadib N, Khalili Pour E, Nikkhah H, Shoeibi N, Hassanpoor N, Hosseini M, Abrishami M, Abdi F, Rahimi A, Jabbarpoor Bonyadi MH, Moradian S, Khosravi Mirzaei S, Safi H, Anvari P, Fadakar K, Mirghorbani M, Mohammadbagheri N, Hatami F, Kheiri B, Yaseri M, Khorrami Z, Ahmadieh H. Effects of repeated intra-silicone oil injections of methotrexate on proliferative vitreoretinopathy grade C: a multicenter randomized controlled trial. Sci Rep. 2024 Nov 21;14(1):28842. doi: 10.1038/s41598-024-79708-1.

    PMID: 39572739DERIVED

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Hamid Ahmadieh, MD

CONTACT

+98 9122195871hahmadieh@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of ophthalmic research center

Study Record Dates

First Submitted

July 18, 2020

First Posted

July 22, 2020

Study Start

August 1, 2020

Primary Completion

July 1, 2021

Study Completion

September 1, 2021

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

IR(1)