Triamcinolone Acetonide Plus Laser Therapy to Treat Age-Related Macular Degeneration
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|ClinicalTrials.gov Identifier: NCT00100009|
Recruitment Status : Completed
First Posted : December 22, 2004
Last Update Posted : July 2, 2017
|First Submitted Date ICMJE||December 21, 2004|
|First Posted Date ICMJE||December 22, 2004|
|Last Update Posted Date||July 2, 2017|
|Study Start Date ICMJE||December 9, 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00100009 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Triamcinolone Acetonide Plus Laser Therapy to Treat Age-Related Macular Degeneration|
|Official Title ICMJE||Multi-Center, Randomized, Phase II/III Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide as an Adjunct to Photodynamic Therapy in Participants With Neovascular Age-Related Macular Degeneration|
This study will test the safety and effectiveness of combining a laser treatment called photodynamic therapy, or PDT, with injections into the eye of the steroid triamcinolone acetonide for treating age-related macular degeneration (AMD). The macula is the part of the retina in the back of the eye that determines central or best vision. AMD can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. This vision loss is caused by the formation of abnormal blood vessels behind the retina that leak blood under the macula. PTD stops the growth of these blood vessels and slows the rate of vision loss; however, it has only a temporary effect and does not work in all patients. Furthermore, it may actually cause some swelling and re-growth of blood vessels. Triamcinolone acetonide can help lessen swelling and scarring.
Patients 50 years of age and older with AMD may be eligible for this study. Candidates are screened with a medical history, medical evaluation, and eye examinations (see below). Participants are randomly assigned to one of three treatment groups: 1) PDT plus 1 mg TAC-PF; 2) PDT plus 4 mg TAC-PF; or 3) PDT plus sham injection (a syringe with no needle is pressed against the eye). Treatments are given the day the patient enrolls in the study and then every 3 months for 2 years, as long as the therapy is thought beneficial. Patients who must discontinue TAC-PF injections may still be treated with PDT if medically necessary. In addition to treatment, patients undergo the following tests and procedures:
Patients are seen in the clinic for additional checks at 4 weeks and 4 months after the first treatment.
Age-related macular degeneration (AMD) represents the most common cause of blindness in persons over the age of 50. The major cause of vision loss in this disease is due to the development of choroidal neovascularization. Several clinical trials have shown that eyes with neovascularization portending 4 disc areas or less or all lesions with predominately classic composition (lesions having at least 50% of vessels which can be readily demarcated with fluorescein angiography) can benefit from treatment with photodynamic therapy (verteporfin - PDT). However, this treatment only results in a reduction in the number of participants who suffer moderate and severe vision loss. Few participants demonstrate an improvement in visual acuity.
Histopathologic studies have demonstrated the presence of an inflammatory response in the retina and choroid of participants with choroidal neovascularization as well as in eyes receiving verteporfin - PDT. Therefore, the use of triamcinolone acetonide, which possesses anti-inflammatory as well as anti-angiogenic properties, may be beneficial in participants with neovascular AMD undergoing verteporfin - PDT.
This study will be organized as a controlled, participant masked, randomized, multi-center Phase II/III study that will investigate the efficacy of a preservative - free intravitreal formulation of triamcinolone acetonide (TAC-PF) in AMD participants undergoing verteporfin - PDT. Unlike studies that use steroids containing benzyl alcohol, this study will evaluate preservative-free steroids. Three hundred participants with neovascular AMD, undergoing verteporfin - PDT, will be randomly assigned to receive either a sham intravitreal injection, a 1 mg intravitreal injection of TAC-PF, or a 4 mg intravitreal injection of TAC-PF. Depending on a participant's response, treatments as randomized, may be repeated at 3-month intervals. Participants will complete a maximum of 2 years of follow-up.
The primary efficacy outcome measure is the proportion of participants who experience a moderate vision loss defined as a drop of greater than or equal to 15 letters in best-corrected visual acuity from baseline verteporfin - PDT treatment to month 12. Secondary outcomes will include assessments of the safety of the adjunct therapy; additional vision changes observed between baseline, month 3, month 12, and month 24; lesion changes observed between baseline, month 3, month 12 and month 24; and changes observed in lens opacities between baseline, month 12, and month 24.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Macular Degeneration|
|Study Arms||Not Provided|
|Publications *||BECKER B, MILLS DW. ELEVATED INTRAOCULAR PRESSURE FOLLOWING CORTICOSTEROID EYE DROPS. JAMA. 1963 Sep 14;185:884-6.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE
|Study Completion Date||December 20, 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
To be eligible for the study, participants must fulfill all of the following criteria:
Participants meeting any of the following criteria will be excluded from the study:
|Ages||50 Years to 100 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00100009|
|Other Study ID Numbers ICMJE||050064
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Eye Institute (NEI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 20, 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP