Multi-Center Randomized Phase I/II Trial to Study the Effects of Cyclooxygenase-2 Inhibition on the Response to Photodynamic Therapy in Patients With Age-Related Macular Degeneration
Age-related macular degeneration (AMD) represents the most common cause of blindness in
patients over the age of 60. 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 predominately 'well-defined' areas of neovascularization (lesions having at least 50%
of vessels which can be readily demarcated with fluorescein angiography) can benefit from
treatment with photodynamic therapy (PDT). However, this treatment benefit only results in
a reduction in the number of patients who suffer severe vision loss. Few patients
demonstrate an improvement in visual acuity. In addition, other neovascular lesions such as
those with predominate occult (vessels that are difficult to outline by fluorescein
angiography) or pure occult do not demonstrate any substantial treatment benefit.
Histopathologic studies have demonstrated the presence of an inflammatory response in the
retina of patients with choroidal neovascularization as well as in eyes receiving PDT. In
addition, in eyes receiving PDT, a vascular remodeling and continued neovascular process
occurs. Therefore, the use of celecoxib (Celebrex® (Registered Trademark)), a specific
cyclooxygenase-2 inhibitor, which possesses both anti-angiogenic as well as
anti-inflammatory properties, may be beneficial in patients with neovascular AMD undergoing
PDT.
The study will be organized as a double-masked, randomized, placebo-controlled, prospective
multi-center clinical trial to investigate the ability of celecoxib to alter the
inflammatory and neovascular responses in AMD patients undergoing PDT. The results of this
study will contribute to the design of a larger definitive clinical trial. The primary
outcome measure is a drop of 15 letters or more in best corrected visual acuity following
initial PDT treatment at 1 year. The secondary outcome measures are stabilization (drop of
4 letters of less from baseline) or improvement of best corrected visual acuity following
initial PDT treatment at week 36, and an improvement by 5 or more letters in visual acuity
from baseline to week 36, time to retreatment with PDT, number of retreatments with PDT and
a change in the CNV size, the extent of leakage and staining detected by fluorescein
angiography. Additional outcome measures will be the change in size and extent of vascular
remodeling and choroidal new vessel formation as determined by optical coherence tomography
(OCT) and high-speed indocyanine green angiography (HS-ICG).
Interventional
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
020257
NCT00043680
August 2002
January 2005
Name | Location |
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National Eye Institute (NEI) | Bethesda, Maryland 20892 |