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 (VERITAS)

• ClinicalTrials.gov Identifier: NCT00242580
• Recruitment Status: Completed
• First Posted: October 20, 2005
• Results First Posted: May 2, 2011
• Last Update Posted: March 31, 2016
• Sponsor: Novartis Pharmaceuticals
• Collaborator: QLT Inc.
• Information provided by: Novartis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Macular Degeneration; Choroidal Neovascularization	Drug: Verteporfin photodynamic therapy; Drug: Pegaptanib; Drug: Triamcinolone acetonide	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: September 2005
• Actual Primary Completion Date: January 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Verteporfin and Triamcinolone 1 mg; Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Drug: Verteporfin photodynamic therapy; After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.; Other Name: Visudyne; Drug: Triamcinolone acetonide; Triamcinolone acetonide administered by intravitreal injection.; Other Name: Kenalog-40®
Experimental: Verteporfin and Triamcinolone 4 mg; Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Drug: Verteporfin photodynamic therapy; After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.; Other Name: Visudyne; Drug: Triamcinolone acetonide; Triamcinolone acetonide administered by intravitreal injection.; Other Name: Kenalog-40®
Active Comparator: Verteporfin and Pegaptanib; Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.	Drug: Verteporfin photodynamic therapy; After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.; Other Name: Visudyne; Drug: Pegaptanib; Pegaptanib sodium 0.3 mg administered by intravitreal injection.; Other Name: Macugen

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline. [ Time Frame: Baseline to Month 12 ]
   BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.

Secondary Outcome Measures :

1. Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12 [ Time Frame: Baseline to Month 12 ]
   BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.
2. Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months [ Time Frame: Baseline to Month 12 ]
   BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline.
3. Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12 [ Time Frame: Baseline to Month 12 ]
   BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline.
4. Number of Participants Requiring Verteporfin Treatment Throughout the Study [ Time Frame: Baseline to Month 12 ]
   Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm.
5. Mean Change From Baseline in Total Area of Lesion at 12 Months [ Time Frame: Baseline to Month 12 ]
   Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Texas

Novartis Investigational Site

Austin, Texas, United States, 78793

Sponsors and Collaborators

Novartis Pharmaceuticals

QLT Inc.

Investigators

• Study Chair: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

Additional Information:

Novartis patient recruitment website: Clinical trial information for patients and caregivers 

• Responsible Party: External Affairs, Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00242580
• Other Study ID Numbers: CBPD952E2202
• First Posted: October 20, 2005
• Results First Posted: May 2, 2011
• Last Update Posted: March 31, 2016
• Last Verified: March 2016

Keywords provided by Novartis:

AMD; age-related macular degeneration; choroidal neovascularization

Additional relevant MeSH terms:

Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic; Retinal Degeneration; Retinal Diseases; Eye Diseases; Metaplasia; Pathologic Processes; Choroid Diseases; Uveal Diseases; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Verteporfin; Triamcinolone diacetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Photosensitizing Agents; Dermatologic Agents