Trial record 14 of 1022 for:    "Macular Degeneration"

Combination Therapy for Neovascular Age Related Macular Degeneration

This study has been withdrawn prior to enrollment.
(Insufficient patients who met inclusion criteria)
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00447031
First received: March 12, 2007
Last updated: February 5, 2010
Last verified: March 2009
  Purpose

Exudative age related macular degeneration (ARMD) is most common cause of blindness in old population. It is clear that no single therapy addresses the multifactorial pathogenesis of the disease. Recently, studies of intravitreal anti-VEGF therapies such as pegaptanib and bevacizumab have shown the beneficial effect in visual acuity in the treatment of neovascular ARMD. However, the problem with these intravitreal injections is that therapy must be frequently administered for a prolonged but unknown period of time to maintain the benefit. Prolonged, frequent injections may be associated with additional safety risk,lack of convenience and high treatment cost.

Intravitreal steroid injection with anti-inflammatory properties limits any further VEGF upregulation initiated by the inflammation which has been known as one of the pathogenesis and causes of recurrence after the treatment of the neovascular ARMD.

The researchers hypothesize that the combined treatment of intravitreal bevacizumab and triamcinolone acetonide may decrease the recurrence rate after the treatment and obviate the frequent intravitreal injections in the treatment of neovascular ARMD.

In this study, the researchers will compare the recurrence rate of combined treatment of intravitreal bevacizumab and triamcinolone acetonide versus intravitreal bevacizumab alone in the treatment of neovascular ARMD.


Condition Intervention
Macular Degeneration
Drug: intravitreal bevacizumab and triamcinolone acetonide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab Combined With Intravitreal Triamcinolone Acetonide Injection Versus Intravitreal Bevacizumab for Age Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • recurrence rate
  • best corrected visual acuity

Secondary Outcome Measures:
  • complication rate

Enrollment: 0
Study Start Date: March 2007
Estimated Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neovascular ARMD confirmed with 90+ noncontact lens biomicroscopy, fluorescein angiography, ocular coherence tomography

Exclusion Criteria:

  • Intractable systemic hypertension
  • Recent myocardial infarct within 6 months at enrollment
  • Recent cerebrovascular attack within 6 months
  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: NCT00447031

Locations
Korea, Republic of
Department of Ophthalmology, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Hyoung Jun Koh YUMC
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00447031     History of Changes
Other Study ID Numbers: koh02
Study First Received: March 12, 2007
Last Updated: February 5, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
age related macular degeneration
intravitreal bevacizumab
intravitreal triamcinolone acetonide
neovascular age related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Bevacizumab
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Enzyme Inhibitors
Glucocorticoids
Growth Inhibitors
Growth Substances
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014