Clinical trial NCT00242580: A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib
Official title: A 24-month Randomized, Double-masked, Sham Controlled, Multicenter, Phase IIIB Study Comparing Photodynamic Therapy With Verteporfin (Visudyne®) Plus Two Different Dose Regimens of Intravitreal Triamcinolone Acetonide (1 mg and 4 mg) Versus Visudyne® Plus Intravitreal Pegaptanib(Macugen®) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Choroidal Neovascularization
Keywords: AMD
age-related macular degeneration
choroidal neovascularization
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: QLT Inc.
First posted: 2005-10-20
Enrollment: 111
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration. The combination treatment consists of verteporfin photodynamic therapy and either triamcinolone acetonide or pegaptanib added as an intravitreal injection.


Eligibility criteria: Inclusion Criteria:

* age \>50
* all types of untreated subfoveal choroidal neovascularization secondary to AMD
* lesion size \<5400 microns in greater linear dimension (GLD)

Exclusion Criteria:

* have a history of prior photodynamic therapy, external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
* known allergy to verteporfin, triamcinolone or pegaptanib
* have received prior treatment with Macugen, or other anti-angiogenic compound or any investigational treatment (e.g. Ruboxistaurin, Lucentis \[ranibizumab\], Retaane \[anecortave acetate\], squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD
* have the presence of fibrosis, hemorrhage, pigment epithelial detachments, tear (tip) of the retinal pigment epithelium or other hypoflourescent lesions obscuring greater than 50% of the CNV lesion
* have had previous pars plana vitrectomy in the study eye

Other protocol-specified inclusion/exclusion criteria applied.

Primary outcomes:
measure: Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12
timeFrame: Baseline to Month 12
measure: Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months
timeFrame: Baseline to Month 12
measure: Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12
timeFrame: Baseline to Month 12
measure: Number of Participants Requiring Verteporfin Treatment Throughout the Study
timeFrame: Baseline to Month 12
measure: Mean Change From Baseline in Total Area of Lesion at 12 Months
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
city: Austin
country: United States
facility: Novartis Investigational Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: