Phase 3
N=111
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
Macular Degeneration · Choroidal Neovascularization
Bottom Line
View on ClinicalTrials.gov: NCT00242580 ↗Enrolled (actual)
111
Serious AEs
27.0%
Results posted
May 2011
Primary outcome: Primary: Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline. — 59.4; 63.4; 71.1 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Verteporfin photodynamic therapy (Drug); Pegaptanib (Drug); Triamcinolone acetonide (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline. |
59.4; 63.4; 71.1 | — |
| SECONDARY Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12 |
31.3; 12.2; 28.9 | — |
| SECONDARY Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months |
18.8; 2.4; 23.7 | — |
| SECONDARY Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12 |
6.3; 0; 13.2 | — |
| SECONDARY Number of Participants Requiring Verteporfin Treatment Throughout the Study |
11; 12; 10; 10; 15; 19 | — |
| SECONDARY Mean Change From Baseline in Total Area of Lesion at 12 Months |
6.9178; 5.6400; 6.3011; 6.8959; 5.8149; 8.6245 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00242580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.