Status:
COMPLETED
Intravitreal v. Sub-tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Macular Degeneration
Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be a promising treatment for a variety of ocular diseases associated with inflammation. To date, the only drug...
Detailed Description
The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be a promising treatment for a variety of ocular diseases associated with inflammation. To date, the only drug...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All Participants must:
- Understand and sign the informed consent.
- Be at least 18 years of age.
- Have definite retinal thickening due to macular edema in the study eye, based on the clinical exam.
- Have retinal thickness greater than or equal to 250 microns in the central subfield on OCT.
- Have BCVA equal to or worse than 20/40 in the study eye.
- Have sufficiently clear ocular media to permit good quality retinal photographs and angiography to allow assessment of macular area according to standard clinical practice.
- Be able to comply with the study requirements.
- EXCLUSION CRITERIA:
- All participants must not:
- Have intraocular pressure greater than 25 or history suggesting glaucoma (e.g., history of the diagnosis of glaucoma, disc/nerve fiber layer defects suggestive of glaucoma) or glaucomatous visual field defects as documented by Goldmann or Humphrey perimetry taken within 6 months to qualification.
- 2\. Be allergic to fluorescein dyes.
- 3\. Have medical conditions that make consistent follow-up over the treatment period unlikely (e.g., stroke, severe MI, end-stage cancer, or history of chronic renal failure requiring dialysis or kidney transplant).
- 4\. Have blood pressure greater than 180/110.
- 5\. Be currently using or be likely to need systemic or ocular medications known to be toxic to the lens, retina, or optic nerve, such as:
- Deferoxamine
- Chloroquine/Hydroxychloroquine (Plaquenil)
- Tamoxifen
- Phenothiazines
- Ethambutol
- 6\. Have used experimental therapies for the present disease in the past 3 months.
- 7\. Have any contraindication to performing the necessary diagnostic procedures.
- 8\. Have a history of or current acute ocular or periocular infection (including any history of ocular herpes zoster or simplex).
- 9\. Have had any major intraocular surgical procedure within one month of enrollment.
- 10\. Have used systemic steroids in excess of an average 20 mg daily dose for the past 3 months.
- 11\. Have a known history of untoward complications from corticosteroid therapy, including elevated intraocular pressure in response to topical or periocular corticosteroids.
Exclusion
Key Trial Info
Start Date :
January 5 2005
Trial Type :
INTERVENTIONAL
End Date :
May 20 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00101764
Start Date
January 5 2005
End Date
May 20 2008
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892