Status:
TERMINATED
Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies
Lead Sponsor:
Wake Forest University
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18-85 years
Phase:
NA
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 excee...
Detailed Description
The most common reason for decreased vision in diabetic retinopathy is macular edema. Current approaches to macular edema include FDA approved interventions such as laser and better underlying control...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00779142
Start Date
September 1 2011
End Date
August 1 2012
Last Update
January 23 2018
Active Locations (1)
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1
Wake Forest Baptist Health Eye Center
Winston-Salem, North Carolina, United States, 27157