Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies
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ClinicalTrials.gov Identifier: NCT00779142 |
Recruitment Status :
Terminated
(recent research indicates Lucentis to be an effictive treatment)
First Posted : October 24, 2008
Results First Posted : June 30, 2014
Last Update Posted : January 23, 2018
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Condition or disease | Intervention/treatment | Phase |
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Diabetic Macular Edema | Drug: Methotrexate intravenous 25mg/ml | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Utility of Intravitreal Methotrexate in Patients With Recalcitrant Diabetic Macular Edema in an Open Label, Nonrandomized, Uncontrolled, Interventional Pilot Trial |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Methotrexate 25mg/ml
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.
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Drug: 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. Statistical analysis would not be applicable in this small sample.
Other Name: Methotrexate |
- 30% Decrease in One Subfield Thickness on Optical Coherence Tomography (OCT) 4 Weeks After the Last Intraocular Injection [ Time Frame: 4 weeks ]
- Number of Participants With Increase in Visual Acuity (VA) Two Lines or More at the End of One Month After the Last Intraocular Injection [ Time Frame: 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. [ Time Frame: 1 month ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Media opacities
- Herpetic disease of cornea
- Corneal dystrophy with significant corneal edema.
- Any major surgery within the last 30 days

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779142
United States, North Carolina | |
Wake Forest Baptist Health Eye Center | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Shree K Kurup, MD | Wake Forest Baptist Health Eye Center |
Responsible Party: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00779142 |
Other Study ID Numbers: |
5865 Methotrexate |
First Posted: | October 24, 2008 Key Record Dates |
Results First Posted: | June 30, 2014 |
Last Update Posted: | January 23, 2018 |
Last Verified: | November 2017 |
resistant diabetic macular edema |
Macular Edema Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
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