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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions: |
Macular Degeneration Choroidal Neovascularization |
| Interventions: |
Drug: Verteporfin photodynamic therapy Drug: Pegaptanib Drug: Triamcinolone acetonide |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| The protocol was amended to limit the sample size from 339 to 100. 111 entered the study and and were part of the 12 mo analysis. The study was subsequently terminated. The patients did not receive study drug during the second year of the study. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Verteporfin + 1 mg Triamcinolone | 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. |
| Verteporfin + 4 mg Triamcinolone | 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. |
| Verteporfin + 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. |
| Verteporfin + 1 mg Triamcinolone | Verteporfin + 4 mg Triamcinolone | Verteporfin + Pegaptanib | |
|---|---|---|---|
| STARTED | 32 | 41 | 38 |
| COMPLETED | 22 [1] | 29 | 24 |
| NOT COMPLETED | 10 | 12 | 14 |
| Adverse Event | 3 | 0 | 2 |
| Unsatisfactory therapeutic effect | 4 | 5 | 5 |
| Protocol Violation | 0 | 0 | 1 |
| Subject withdrew consent | 2 | 2 | 5 |
| Lost to Follow-up | 0 | 3 | 0 |
| Adminstrative problems | 0 | 0 | 0 |
| Death | 1 | 2 | 1 |
| [1] | "Completed" indicates 12 month data. |
|---|
Baseline Characteristics
| Description | |
|---|---|
| Verteporfin + 1 mg Triamcinolone | 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. |
| Verteporfin + 4 mg Triamcinolone | 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. |
| Verteporfin + 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. |
| Verteporfin + 1 mg Triamcinolone | Verteporfin + 4 mg Triamcinolone | Verteporfin + Pegaptanib | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
32 | 41 | 38 | 111 |
|
Age
[units: years] Mean ± Standard Deviation |
76 ± 9 | 78 ± 8 | 81 ± 6 | 78 ± 8 |
|
Gender
[units: participants] |
||||
| Female | 18 | 25 | 20 | 63 |
| Male | 14 | 16 | 18 | 48 |
|
Region of Enrollment
[units: participants] |
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| United States | 32 | 41 | 38 | 111 |
Outcome Measures
| 1. Primary: | 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 ] |
| 2. Secondary: | 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 ] |
| 3. Secondary: | Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months [ Time Frame: Baseline to Month 12 ] |
| 4. Secondary: | Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12 [ Time Frame: Baseline to Month 12 ] |
| 5. Secondary: | Number of Participants Requiring Verteporfin Treatment Throughout the Study [ Time Frame: Baseline to Month 12 ] |
| 6. Secondary: | Mean Change From Baseline in Total Area of Lesion at 12 Months [ Time Frame: Baseline to Month 12 ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
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| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| 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. |
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00242580 History of Changes |
| Other Study ID Numbers: | CBPD952E2202 |
| Study First Received: | October 19, 2005 |
| Results First Received: | January 24, 2011 |
| Last Updated: | April 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |