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Study was terminated because of poor enrollment.
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| Name | Class |
|---|---|
| QLT Inc. | INDUSTRY |
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VERTACL will investigate whether a triple therapy, Avastin®, half fluence verteporfin photodynamic therapy (PDT), and triamcinolone acetonide-preservative free (TAC- PF), results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.
The VERTACL study is a multi-center, randomized, Phase II trial to investigate whether a triple therapy, Avastin®, half fluence verteporfin PDT, and TAC- PF, results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.
Participants will be randomized (similar to the flip of a coin) in a 1:1 ratio to one of the two study groups: single therapy (Avastin®), or triple therapy (Avastin®, half fluence verteporfin PDT, and TAC- PF). Participants in the Avastin® alone arm will receive 1.25 mg intravitreal Avastin®, at every study visit. Participants in the triple-therapy arm will receive all treatments (Avastin®, half fluence verteporfin PDT, and TAC- PF) at baseline.
Following baseline, participants in the triple therapy study arm will receive study treatment on an as-needed (PRN) basis if protocol-specific re-treatment criteria are met. After randomization, participants will return to the clinic approximately every six weeks for one year for study assessments and possible re-treatment.
Participants will return to the clinic at month 24 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography, and fundus photography.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin | Drug | |||
| Photodynamic Therapy (PDT) | Procedure | |||
| Preservative-Free Triamcinolone Acetonide (TAC-PF) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean and median change in ETDRS BCVA from baseline to months 3, 6, and 24. | ||
| Proportion of participants avoiding a loss of ³ 15 letters in ETDRS BCVA by months 3, 6, 12, and 24 | ||
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Inclusion Criteria Includes:
Exclusion Criteria Includes:
Study Eye Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Karl G Csaky, MD, PhD | Duke University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Group of Florida | Fort Lauderdale | Florida | 33334 | United States | ||
| Central Florida Retina- Orlando |
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| Proportion of participants improving by ³ 15 letters in ETDRS BCVA at months 3, 6, 12, and 24. |
| Proportion of participants who show any improvement in ETDRS BCVA at months 3, 6, 12, and 24. |
| Mean change in the total lesion area (Disc Areas) from baseline to months 3, 6, 12, and 24. |
| Mean change in area of CNV (Disc Areas) at months 3, 6, 12, and 24. |
| Mean change in area of leakage (Disc Areas) at months 3, 6, 12, and 24. |
| Proportion of classic CNV out of the entire lesion from baseline to months 3, 6, 12, and 24. |
| Changes in mean excess retinal thickening in the center subfield (i.e., thickness >175 microns) from baseline to months 3, 6, 12, and 24. |
| Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 175 microns) of ³50% and of at least 50 microns from baseline to months 3, 6, 12, and 24. |
| The overall probability of re-injection (excluding injections precluded for safety concerns) through Month 12. |
| The mean number of injections by quarter on study following initial induction injections. |
| Orlando |
| Florida |
| 32746 |
| United States |
| Retina Specialists | Pensacola | Florida | 32503 | United States |
| Elman Retina Group- Baltimore | Baltimore | Maryland | 21237 | United States |
| Associated Retinal Consulants | Grand Rapids | Michigan | 49546 | United States |
| VitroRetinal Surgery | Minneapolis | Minnesota | 55435 | United States |
| Duke University Eye Center | Durham | North Carolina | 27710 | United States |
| Palmetto Retina Center | Columbia | South Carolina | 29204 | United States |
| Southeastern Retina Associates | Knoxville | Tennessee | 37909 | United States |
| Texas Retina Associates-Arlington | Arlington | Texas | 76012 | United States |
| Texas Retina Associates-Dallas | Dallas | Texas | 85231 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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