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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000848-26 | EudraCT Number |
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| Name | Class |
|---|---|
| TFS Trial Form Support | INDUSTRY |
| Bayer | INDUSTRY |
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Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5mg AFLIBERCEPT injection | Experimental | Patients will receive intravitreal injection of aflibercept 0.5mg at baseline, week 4,8,16,24 and 32. Optionally, if intra or subretinal fluid persists at week 12, patients will receive an additional injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5mg aflibercept | Drug | 0.5mg aflibercept intravitreal injection will be performed every 4 weeks from baseline to week 8 (3 doses) and every 8 weeks until week 32. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept | At week 12 an OCT will be performed to evaluate the changes in intra or subretinal fluid and to determine the percentage of patients with no fluid after 3 doses of aflibercept injected on baseline visit, week 4 and week 8. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in best corrected visual acuity (BCVA)after loading dose | week 12 | |
| Changes in OCT central foveal thickness after loading dose | week 12 | |
| Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment. |
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Inclusion Criteria:
Signed Informed Consent
Men and women ≥ 50 years of age.
Any choroidal neovascular membranes (CNVM) lesion (occult, minimally classic or classic) secondary to age-related macular degeneration
Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye.
Able to return for ALL clinic visits and complete all study-related procedures.
Absence of other ocular diseases that could affect visual acuity.
Patients without optimal response to ranibizumab or bevacizumab defined as:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordi Mones, MD PhD | Barcelona Macula Foundation | Principal Investigator |
| Carlos Juan Donate, MD | Hospital San Carlos, Madrid | Principal Investigator |
| Marta Suárez de Figueroa, MD | Hosipital Universitario Ramon y Cajal | Principal Investigator |
| Jose Luis Olea, MD | Hospital Son Espases | Principal Investigator |
| Francisco Cabrera, MD | Hospital Universitario Insular de Canarias | Principal Investigator |
| Laura Sarasols, MD | Hospital Universitari General de Catalunya | Principal Investigator |
| Javier Araiz, MD | Instituto ClÃnico Quirúrgico de OftalmologÃa de Bilbao | Principal Investigator |
| Jose Maria Ruiz-Moreno, MD | Hospital Universitario de Albacete | Principal Investigator |
| Ignasi Jürgens, MD PhD | Institut Catala de Retina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barcelona Macula Foundation | Barcelona | 08022 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 22, 2021 | |
| Reset | May 13, 2021 | |
| Release | May 14, 2021 |
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|
| week 40 |
| Determine the time to resolution of any intra/sub retinal fluid on OCT | week 4,8,12,24,32,40 |
| Describe safety of this cohort of patients | Describe the safety of aflibercept in study patients by determining ocular and non ocular adverse events classified according to type, frequency and severity during 40 weeks | baseline, week 4, 8, 12, 24, 32 and 40 |
| Reset | Jun 8, 2021 |
| Release | Jun 9, 2021 |
| Reset | Jun 29, 2021 |
| Release | Jun 30, 2021 |
| Reset | Jul 20, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 22, 2021 | May 13, 2021 | |||
| May 14, 2021 | Jun 8, 2021 | |||
| Jun 9, 2021 | Jun 29, 2021 | |||
| Jun 30, 2021 | Jul 20, 2021 |
| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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