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AzTrials

Diabetic RetinopathyEarly Phase 1NCT06038968

Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

A Early Phase 1 study testing Methotrexate 25 MG/ML and parsplana vitrectomy in people with Diabetic Retinopathy and Vitreomacular Traction, run by Minia University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this interventional clinical trial is to assess anatomical and functional outcomes of methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery in patients with advanced proliferative diabetic retinopathy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Retinopathy, Vitreomacular Traction
What is being tested?
Methotrexate 25 MG/ML and parsplana vitrectomy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Sep 2022to 1 Jan 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with diabetic tractional macular detachment or combined tractional- rhegmatogenous retinal detachment

Who cannot join

  • Previous vitreoretinal surgery.
  • Pregnant or lactating female.
  • Co-existing pathology that might induce PVR such as penetrating ocular trauma or uveitis, co-existing congenital anomalies or hereditary vitreoretinopathies

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • ophthalmology department, Minia university hospital

    Minya, Minya Governorate, 61519

Other trials in Egypt

About this study

Official title: Anatomical and Functional Outcomes of Use of Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

The goal of this interventional clinical trial is to assess anatomical and functional outcomes of methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery in patients with advanced proliferative diabetic retinopathy.

The main questions it aims to answer are:

Read more
  1. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery decrease the post operative vitreoretinal proliferation after vitrectomy in patients with advanced proliferative diabetic retinopathy?
  2. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery improve post operative functional outcome after vitrectomy in patients with advanced proliferative diabetic retinopathy?

Researchers will compare the anatomical and functional outcomes after vitrectomy in patients with advanced proliferative diabetic retinopathy without using methotrexate.

Read the detailed description

Tractional macular detachment (TMD) or macula threatening tractional retinal detachment (TRD) and combined tractional-rhegmatogenous retinal detachment (TRD/RRD) are considered as important indications for vitreoretinal intervention.

Although a growing number of eyes with TMD and TRD/RRD are successfully treated with a single procedure, retinal re-detachment associated with fibrovascular proliferation or proliferative vitreoretinopathy (PVR) is still a major cause of failure of the surgery.

Previous studies have shown increased expression of inflammatory cytokines and growth factors in both proliferative diabetic retinopathy (PDR) and PVR.

Methotrexate (MTX) is an anti-neoplastic and anti-inflammatory agent used to treat a variety of malignancies and rheumatologic diseases.

In ophthalmology, systemic and intraocular MTX has been successfully used for indeterminate uveitis, sarcoid uveitis and intraocular lymphoma.

MTX has been recently found to inhibit PVR by stopping cellular proliferation and promoting organized apoptosis. MTX has also been found to be effective in lowering the incidence of PVR when used as an adjunct in irrigation fluid during vitrectomy for retinal detachment.

Being tested
Methotrexate 25 MG/ML, parsplana vitrectomy
Keywords
Methotrexate, proliferative diabetic retinopathy
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methotrexate 25 MG/MLDrug

    Also called Methotrexate Mylan 50 mg/2 mL

    Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division.

  • parsplana vitrectomyProcedure or surgery

    Pars plana vitrectomy (PPV) is a technique in vitreoretinal surgery that enables access to the posterior segment for treating tractional retinal detachment in advanced proliferative diabetic retinopathy, in a controlled, closed system.

Study groups in NCT06038968
Study groupRoleWhat they receive
Methotrexate groupExperimentalmethotrexate group will receive 40 mg of MTX in 500 ml of irrigation fluid during vitrectomy and 250 ug intra-silicone oil injection at the end of vitrectomy
Receives: Drug: Methotrexate 25 MG/ML; Procedure: parsplana vitrectomy
Control groupPlacebo comparatorcontrol group will not receive MTX in irrigation fluid during vitrectomy nor intra-silicone at the end of vitrectomy
Receives: Procedure: parsplana vitrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assess retinal layers by optical coherence tomography

    presence of epiretinal membrane, cystic changes in retina, central macular thickens

    Measured: one month after pars plana vitrectomy and one month after silicone oil evacuation

  2. assess functional outcomes by multifocal electroretinogram

    latency and amplitude of main P wave

    Measured: one month after pars plana vitrectomy and one month after silicone oil evacuation

Secondary outcomes (2)

  1. Anterior segment slit lamp biomicroscopic examination

    assess anterior segment inflammation as iritis or posterior synechia

    Measured: one month after pars plana vitrectomy

  2. visual acuity

    by logMAR (Logarithm of the Minimum Angle of Resolution)

    Measured: one month after pars plana vitrectomy and one month after silicone oil evacuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start1 Sep 2022
  3. Primary completion1 Nov 2023
  4. Study completion1 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06038968
Sponsor's protocol ID
MTX DM vitrectomy
Status last verified
Sep 2023
First submitted
8 Sep 2023
Last updated
5 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: email the main investigator for requested data

Publications

  • Newman DK. Surgical management of the late complications of proliferative diabetic retinopathy. Eye (Lond). 2010 Mar;24(3):441-9. doi: 10.1038/eye.2009.325. Epub 2010 Feb 5.

    PubMed 20139916

  • Meleth AD, Carvounis PE. Outcomes of vitrectomy for tractional retinal detachment in diabetic retinopathy. Int Ophthalmol Clin. 2014 Spring;54(2):127-39. doi: 10.1097/IIO.0000000000000021. No abstract available.

    PubMed 24613889

  • Gologorsky D, Thanos A, Vavvas D. Therapeutic interventions against inflammatory and angiogenic mediators in proliferative diabetic retinopathy. Mediators Inflamm. 2012;2012:629452. doi: 10.1155/2012/629452. Epub 2012 Sep 17.

    PubMed 23028203

  • Zhou J, Wang S, Xia X. Role of intravitreal inflammatory cytokines and angiogenic factors in proliferative diabetic retinopathy. Curr Eye Res. 2012 May;37(5):416-20. doi: 10.3109/02713683.2012.661114. Epub 2012 Mar 12.

    PubMed 22409294

  • Ricker LJ, Kijlstra A, Kessels AG, de Jager W, Liem AT, Hendrikse F, La Heij EC. Interleukin and growth factor levels in subretinal fluid in rhegmatogenous retinal detachment: a case-control study. PLoS One. 2011 Apr 27;6(4):e19141. doi: 10.1371/journal.pone.0019141.

    PubMed 21556354

  • Samson CM, Waheed N, Baltatzis S, Foster CS. Methotrexate therapy for chronic noninfectious uveitis: analysis of a case series of 160 patients. Ophthalmology. 2001 Jun;108(6):1134-9. doi: 10.1016/s0161-6420(01)00576-0.

    PubMed 11382642

  • Smith JR, Rosenbaum JT, Wilson DJ, Doolittle ND, Siegal T, Neuwelt EA, Pe'er J. Role of intravitreal methotrexate in the management of primary central nervous system lymphoma with ocular involvement. Ophthalmology. 2002 Sep;109(9):1709-16. doi: 10.1016/s0161-6420(02)01125-9.

    PubMed 12208721

  • Amarnani D, Machuca-Parra AI, Wong LL, Marko CK, Stefater JA, Stryjewski TP, Eliott D, Arboleda-Velasquez JF, Kim LA. Effect of Methotrexate on an In Vitro Patient-Derived Model of Proliferative Vitreoretinopathy. Invest Ophthalmol Vis Sci. 2017 Aug 1;58(10):3940-3949. doi: 10.1167/iovs.16-20912.

    PubMed 28777835

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Methotrexate 25 MG/ML and parsplana vitrectomy in people with Diabetic Retinopathy and Vitreomacular Traction, run by Minia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assess retinal layers by optical coherence tomography (time frame: one month after pars plana vitrectomy and one month after silicone oil evacuation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06038968, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.

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