Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies

NCT00779142 | Terminated Results

• 1 other identifier: 5865 Methotrexate
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

It is well known that blindness is one of the most feared disabilities expressed by patients in the United States. Estimates of the economic impact of visual disability in the current population exceed 30 million US dollars in this country alone. The reasons for this figure are many; however age related macular degeneration (ARMD), diabetic retinopathy, glaucoma and uveitis are responsible for the majority of permanent visual disability and hence the costs in both quality of life and placing an economic burden on society. Research that may help reverse various abnormal biological responses that lead to or worsen clinical manifestations of diabetic retinopathy would be valuable.

Conditions

Diabetic Macular Edema

Keywords

resistant diabetic macular edema

Outcome Measures

Primary Outcomes (1)

• 30% Decrease in One Subfield Thickness on Optical Coherence Tomography (OCT) 4 Weeks After the Last Intraocular Injection

  4 weeks

Secondary Outcomes (2)

• Number of Participants With Increase in Visual Acuity (VA) Two Lines or More at the End of One Month After the Last Intraocular Injection

  1 month

• Secondary Would be Significant Clinical Improvement (Judged at the Slit Lamp Exam Using a 90D Lens) in Macular Edema at the End of One Month After the Last Intraocular Injection.

  1 month

Study Arms (1)

Methotrexate 25mg/ml

OTHER

Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose to subjects with diabetic macular edema resistant to conventional therapies.

Drug: Methotrexate intravenous 25mg/ml

Interventions

Methotrexate intravenous 25mg/ml DRUG

Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.

Also known as: Methotrexate

Methotrexate 25mg/ml

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years and older) with clinically significant macular edema (CSME) with visual acuity less than 20/60 to Hand motion in the study eye.
• Patients should have persistent CSME three months after laser therapy or three months after intraocular injection of Avastin or triamcinolone. These interventions could be multiple or combined.
• Optical coherence tomography (OCT) scan demonstrating more than 275 microns retinal thickness in central subfield of study eye.
• Ability to understand study instructions, interventions and potential complications.
• History of reasonably controlled Diabetes mellitus (DM), ≤ 8.5HbA1c that has been evaluated in the last 3 months.
• Ability to undergo contraceptive protection during and 3 months after intraocular injections.
• Clear demonstration (in female patients) of commitment to avoid pregnancy and a negative urine pregnancy test at baseline for women of childbearing potential.
• Clear understanding of teratogenic potential of MTX.

You may not qualify if:

• History of allergy to MTX.
• An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition.
• An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, epiretinal membrane, etc.).
• An eye treated for Glaucoma
• Eyes that underwent vitrectomy
• History of intraocular malignancies.
• Intraocular surgery with the prior 3 months.
• Recent significant change in diabetic medications.
• Insulin usage less than a year.
• Life threatening co morbidities such as cancer under therapy.
• Use of oral, intravenous, periocular or intraocular corticosteroids (steroids) in prior 3 months.
• Liver function that exceeds three times the upper limit of normal at baseline, or within 6 weeks of that appointment.
• Pregnant females.
• Vitreous hemorrhage (active) in study eye
• Anticipation of the need for laser pan retinal photocoagulation in the next 6 months.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest Baptist Health Eye Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (6)

• Rein DB, Zhang P, Wirth KE, Lee PP, Hoerger TJ, McCall N, Klein R, Tielsch JM, Vijan S, Saaddine J. The economic burden of major adult visual disorders in the United States. Arch Ophthalmol. 2006 Dec;124(12):1754-60. doi: 10.1001/archopht.124.12.1754.

  PMID: 17159036 BACKGROUND

• Shimura M, Nakazawa T, Yasuda K, Shiono T, Iida T, Sakamoto T, Nishida K. Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on persistent diffuse diabetic macular edema. Am J Ophthalmol. 2008 May;145(5):854-61. doi: 10.1016/j.ajo.2007.12.031. Epub 2008 Mar 6.

  PMID: 18328456 BACKGROUND

• Vasconcelos-Santos DV, Nehemy PG, Schachat AP, Nehemy MB. Secondary ocular hypertension after intravitreal injection of 4 mg of triamcinolone acetonide: incidence and risk factors. Retina. 2008 Apr;28(4):573-80. doi: 10.1097/IAE.0b013e31816079e8.

  PMID: 18398360 BACKGROUND

• Hartley KL, Smiddy WE, Flynn HW Jr, Murray TG. Pars plana vitrectomy with internal limiting membrane peeling for diabetic macular edema. Retina. 2008 Mar;28(3):410-9. doi: 10.1097/IAE.0b013e31816102f2.

  PMID: 18327132 BACKGROUND

• Hardwig PW, Pulido JS, Erie JC, Baratz KH, Buettner H. Intraocular methotrexate in ocular diseases other than primary central nervous system lymphoma. Am J Ophthalmol. 2006 Nov;142(5):883-5. doi: 10.1016/j.ajo.2006.06.002.

  PMID: 17056381 BACKGROUND

• Ghajarnia M, Kurup S, Eller A. The therapeutic effects of intravitreal bevacizumab in a patient with recalcitrant idiopathic polypoidal choroidal vasculopathy. Semin Ophthalmol. 2007 Apr-Jun;22(2):127-31. doi: 10.1080/08820530701421635.

  PMID: 17564935 BACKGROUND

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Shree Kurup
• Organization: Wake Forest Baptist Health Eye Center

skurup@wakehealth.edu

336-716-4091

Study Officials

• Shree K Kurup, MD

  Wake Forest Baptist Health Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: September 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 23, 2018
• Results First Posted: June 30, 2014

Record last verified: 2017-11

Locations

US (1)