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

Primary Purpose

Macular Degeneration, Retinal Vein Occlusion, Diabetic Retinopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 12, 2005
Last Updated
June 30, 2017
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00101764
Brief Title
Intravitreal v. Sub-tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders
Official Title
Phase I Study of Intravitreal Injections Versus Anterior Sub-Tenon Injections of Triamcinolone Acetonide Formulation for Macular Edema in Retinal Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 20, 2008
Overall Recruitment Status
Completed
Study Start Date
January 5, 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 20, 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Retinal Vein Occlusion, Diabetic Retinopathy
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8351091
Citation
Bodker FS, Ticho BH, Feist RM, Lam TT. Intraocular dexamethasone penetration via subconjunctival or retrobulbar injections in rabbits. Ophthalmic Surg. 1993 Jul;24(7):453-7.
Results Reference
background

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

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