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IRB stopped study due to safety concerns before any participants were enrolled.
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| Name | Class |
|---|---|
| Modulight | UNKNOWN |
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Optical Coherent Tomography Angiography (OCTA)-Directed PDT Triple Therapy for Treatment-Naïve Patients with Exudative Age-related Macular Degeneration (ARMD) versus Standard of Care Anti-VEGF Monotherapy
This study is a 48 week, single center, randomized controlled clinical trial. Approximately 150 subjects will be randomized into three separate arms. This study compares the efficacy of standard of care Lucentis (ranibizumab) monotherapy versus OCTA-Directed PDT Triple Therapy with Lucentis (ranibizumab), PDT with Visudyne (verteporfin), and Triescence (triamcinolone acetonide) in treatment-naïve patients with Exudative Age-Related Macular Degeneration. OCTA-Directed PDT Double Therapy with Lucentis (ranibizumab) and PDT with Visudyne (verteporfin) will also be tested to confirm the hypothesis that steroids are necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Lucentis | Active Comparator | A standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks. |
|
| Arm B: Lucentis & PDT Laser | Experimental | A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence. |
|
| Arm C: Lucentis, PDT Laser and Triescense | Experimental | A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence and an intravitreal injection of 0.5ml-2mg Triescence at the time of PDT treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Intravitreal injection 0.5 MG Per 0.05 ML Injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subretinal exudation resolution | The percentage of subretinal exudation resolution | 6 months |
| Percentage of intraretinal exudation resolution | The percentage of intraretinal exudation resolution | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subretinal exudation resolution | Subretinal exudation resolution | 12 months |
| Percentage of intraretinal exudation resolution | Intraretinal exudation resolution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Nelson, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
Results will updated once final analysis is complete.
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| D000077362 | Verteporfin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Photodynamic laser treatment (PDT) | Device | PDT light dose of 50 J/cm2 of neovascular lesion administered at an intensity of 600mW/cm2. A Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area. PDT will be administered at half-fluence - measured by time, i.e. 42 seconds as opposed to full-fluence which is 83 seconds. |
|
| Triamcinolone Acetonide | Drug | Intravitreal injection of 0.5ml-2mg |
|
|
| verteporfin | Drug | Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area. |
|
|
| 12 months |
| Best corrected visual acuity (BCVA) | Best corrected visual acuity | Baseline |
| Best corrected visual acuity (BCVA) | Best corrected visual acuity | 12 months |
| Duration of treatment effect | Duration of treatment effect | Up to 6 months |
| Foveal thickness | Measured using Optical coherence tomography (OCT) | Baseline |
| Foveal thickness | Measured using Optical coherence tomography (OCT) | 12 Months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |