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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.
This is an open-label, non-randomized, unmasked, study of IAI in patients with choroidal neovascularization secondary to polypoidal choroidal vasculopathy (PCV). Twenty treatment naïve and previously treated PCV eyes will be enrolled (only one study eye per patient will be enrolled). A maximum of 10 previously treated eyes will be enrolled. Consented, enrolled patients will be followed monthly. All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months. Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met. Starting at Month 3, patients can receive non-anti vascular endothelial growth factor (VEGF) rescue therapy (ie: Photodynamic Therapy (PDT), laser, intravitreal steroids) if the pre-defined criteria are met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal Aflibercept Injection | Other | All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rescue Intravitreal Aflibercept Injection | Drug | Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity | The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 6. | Month 6 |
| Incidence and Severity | The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 12. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) | •The mean change in BCVA from Baseline to Month 6 and from Baseline up to 12 months | Months 6 and 12 |
| Change in Best Corrected Visual Acuity (BCVA) |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Therapy | •Mean number of injections of IAI | Month 12 |
| Rescue Therapy | •Incidence of need and administration of rescue therapy with PDT, laser, or intravitreal steroids |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siobhan Ortiz | Contact | 706-650-0061 | siobhan@southeastretina.com |
| Name | Affiliation | Role |
|---|---|---|
| Dennis M Marcus, MD | Part-Owner of Southeast Retina Center, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Retina Center, PC | Recruiting | Augusta | Georgia | 30909 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 8, 2019 | |
| Reset | May 1, 2019 |
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| Rescue Therapy with PDT, Laser or Intravitreal Steroids | Procedure | Starting at Month 3, patients can receive non-anti VEGF rescue therapy (ie: PDT, laser, intravitreal steroids) if the pre-defined criteria are met. |
|
•Proportion of patients gaining 5, 10 and 15 letters at Months 6 and 12
| Months 6 and 12 |
| Change in Best Corrected Visual Acuity (BCVA) | •Proportion of patients losing 5,10, and 15 letters at Months 6 and 12 | Months 6 and 12 |
| Photography Assessments | •Mean change from baseline in central subfield thickness at Months 6 and 12 as assessed on spectral domain optical coherence tomography (SD-OCT) | Months 6 and 12 |
| Photography Assessments | •Mean change from baseline in macular volume at Months 6 and 12 as assessed on SD-OCT | Months 6 and 12 |
| Photography Assessments | •Mean change from baseline in choroidal thickness at Months 6 and 12 through SD-OCT | Months 6 and 12 |
| Photography Assessments | •Proportion of patients with no evidence of pigment epithelial detachment (PED), intraretinal and subretinal fluid from choroidal neovascularization (CNV) as assessed by optical coherence tomography (OCT) at 6 and 12 months | Months 6 and 12 |
| Photography Assessments | •Mean change from baseline in the total area of CNV fluorescein angiographic leakage at months 6 and 12 | Months 6 and 12 |
| Photography Assessments | •Fluorescein angiograms, indocyanine green (ICG) angiograms, OCT and fundus photographs at Months 6 and 12 compared to baseline as unchanged, resolved, improved, worsened, or cannot determine. See section 9.1.2.2 | Months 6 and 12 |
| Photography Assessments | •Rate of polyp regression and resolution at 6 and 12 Months | Months 6 and 12 |
| Month 12 |
| Rescue Therapy | •Incidence and need of administration of additional IAI therapy | Month 12 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 8, 2019 | May 1, 2019 |
| ID | Term |
|---|---|
| C008848 | 1-phenyl-3,3-dimethyltriazene |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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