Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intravitreal v. Sub-Tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00101764
First received: January 12, 2005
Last updated: May 21, 2008
Last verified: May 2008
  Purpose

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 available, "Kenalog-40 Injection" produced by Bristol Myers Squibb, has not been formulated for intraocular use.

The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide (TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of TAC-PF at 20 mg.

The study will be a masked, randomized Phase I study that will enroll 120 participants with one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema (DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any other retinal disease with associated macular edema. At least 21 participants will be enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease. Within each disease strata, at least seven participants will be randomized to each dosing group. The participants will be randomly assigned to one of the three treatment groups.

The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up, including cataract formation, development of glaucoma, and any adverse event preventing retreatment. The secondary outcomes will be an improvement in best-corrected visual acuity (BCVA, EVA) and decreases in retinal thickening and area of leakage, from baseline to year 1.


Condition Intervention Phase
Macular Degeneration
Retinal Vein Occlusion
Diabetic Retinopathy
Drug: Triamcinolone Acetonide
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Intravitreal Injections Versus Anterior Sub-Tenon Injections of Triamcinolone Acetonide Formulation for Macular Edema in Retinal Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: January 2005
Estimated Study Completion Date: May 2008
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 available, "Kenalog-40 Injection" produced by Bristol Myers Squibb, has not been formulated for intraocular use.

The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide (TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of TAC-PF at 20 mg.

The study will be a masked, randomized Phase I study that will enroll 120 participants with one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema (DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any other retinal disease with associated macular edema. At least 21 participants will be enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease. Within each disease strata, at least seven participants will be randomized to each dosing group. The participants will be randomly assigned to one of the three treatment groups. Depending on a participant's response, injections may be repeated at 3-month intervals. Participants will be followed until the last enrolled participant completes 3 years of follow-up.

The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up, including cataract formation, development of glaucoma, and any adverse event preventing retreatment. The secondary outcomes will be an improvement in best-corrected visual acuity (BCVA) and decreases in retinal thickening and area of leakage, from baseline to year 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

All Participants must:

  1. Understand and sign the informed consent.
  2. Be at least 18 years of age.
  3. Have definite retinal thickening due to macular edema in the study eye, based on the clinical exam.
  4. Have retinal thickness greater than or equal to 250 microns in the central subfield on OCT.
  5. Have BCVA equal to or worse than 20/40 in the study eye.
  6. Have sufficiently clear ocular media to permit good quality retinal photographs and angiography to allow assessment of macular area according to standard clinical practice.
  7. 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:

    1. Deferoxamine
    2. Chloroquine/Hydroxychloroquine (Plaquenil)
    3. Tamoxifen
    4. Phenothiazines
    5. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101764

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00101764     History of Changes
Other Study ID Numbers: 050071, 05-EI-0071
Study First Received: January 12, 2005
Last Updated: May 21, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
AMD
CRVO
BRVO
Uveitis
Choroidal Neovascularization
Age-Related Macular Degeneration (AMD)
Macular Edema
Central Retinal Vein Occlusion
Branch Retinal Vein Occlusion
Inflammation
Age Related Macular Degeneration
Retinal Disorder

Additional relevant MeSH terms:
Diabetic Retinopathy
Macular Degeneration
Macular Edema
Retinal Diseases
Retinal Vein Occlusion
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Embolism and Thrombosis
Endocrine System Diseases
Eye Diseases
Retinal Degeneration
Thrombosis
Vascular Diseases
Venous Thrombosis
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014