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

NCT00242580 | Completed Phase 3 Results

• 1 other identifier: CBPD952E2202
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration; Choroidal Neovascularization

Keywords

AMD; age-related macular degeneration; choroidal neovascularization

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.

  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.

  Baseline to Month 12

Secondary Outcomes (5)

• Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12

  Baseline to Month 12

• Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months

  Baseline to Month 12

• Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12

  Baseline to Month 12

• Number of Participants Requiring Verteporfin Treatment Throughout the Study

  Baseline to Month 12

• Mean Change From Baseline in Total Area of Lesion at 12 Months

  Baseline to Month 12

Study Arms (3)

Verteporfin and Triamcinolone 1 mg

EXPERIMENTAL

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; Drug: Triamcinolone acetonide

Verteporfin and Triamcinolone 4 mg

EXPERIMENTAL

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; Drug: Triamcinolone acetonide

Verteporfin and Pegaptanib

ACTIVE COMPARATOR

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; Drug: Pegaptanib

Interventions

Verteporfin photodynamic therapy DRUG

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.

Also known as: Visudyne

Verteporfin and Pegaptanib; Verteporfin and Triamcinolone 1 mg; Verteporfin and Triamcinolone 4 mg

Pegaptanib DRUG

Pegaptanib sodium 0.3 mg administered by intravitreal injection.

Also known as: Macugen

Verteporfin and Pegaptanib

Triamcinolone acetonide DRUG

Triamcinolone acetonide administered by intravitreal injection.

Also known as: Kenalog-40®

Verteporfin and Triamcinolone 1 mg; Verteporfin and Triamcinolone 4 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• QLT Inc.: collaborator

Study Sites (1)

Novartis Investigational Site

Austin, Texas, 78793, United States

Location

Related Links

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

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Verteporfin; pegaptanib; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Limitations and Caveats

Secondary outcome measures were to be assessed at Month 6 and at 24 months. However, this study was not completed but terminated after all patients completed 12 months. Original safety was COSTART now mapped to SOC MedDRA.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 20, 2005
• Study Start: September 1, 2005
• Primary Completion: January 1, 2008
• Last Updated: March 31, 2016
• Results First Posted: May 2, 2011

Record last verified: 2016-03

Locations

US (1)