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There are limited prospective data regarding the potential benefit and risks associated with switching between anti-VEGF therapies in patients with nAMD who have initially achieved a favorable response to the first anti-VEGF therapy used but subsequently have evidence of increasing disease activity despite continuation of therapy. This study will fill this knowledge gap by prospectively evaluating the effectiveness and safety of switching from aflibercept to ranibizumab in nAMD patients that have non - sustained response to initial treatment with aflibercept.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab at 0.5 mg | Experimental | Single arm, intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | 0.5 mg, intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Central Subfield Retinal Thickness (CSRT) | Change (in absolute and percentage terms) in central subfield retinal thickness (CSRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT). | at Day 90 (Month 3) and Day 180 (Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Central Subfield Retinal Thickness (CSRT) | Change (in absolute and percentage terms) in central subfield retinal thickness (CSRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT). | Monthly, from baseline to Month 6 |
| Mean change in Subfoveal Retinal Thickness (SRT) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for ocular medical history and conditions for either eye:
Study eye exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Change (in absolute and percentage terms) in subfoveal retinal thickness (SRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT). |
| Monthly, from baseline to Month 6 |
| Change in Central Subfield Retinal Volume (CSRV) | Change (in absolute and percentage terms) in subfoveal retinal thickness (SRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT). | Monthly, from baseline to Month 6 |
| Mean change in Subretinal Fluid (SF) | Measured through Optical Coherence Tomography (OCT). | Monthly, from baseline to Month 6 |
| Mean change in Intra-Retinal Cystoid changes (IRCs) volume | Measured through Optical Coherence Tomography (OCT). | Monthly, from baseline to Month 6 |
| Mean change in Pigment Epithelial Detachments (PEDs) | Measured through Optical Coherence Tomography (OCT). | Monthly, from baseline to Month 6 |
| Mean change of Best-Corrected Visual Acuity (BCVA) | Best-corrected visual acuity (BCVA) will be assessed in a sitting position using subjective refraction and ETDRS-like visual acuity testing charts. | Monthly, from baseline to Month 6 |
| Rate of change in Subfoveal Retinal Thickness (SRT) | Rates will be assessed with the proportion of patients with changes. | Monthly, from baseline to Month 6 |
| Rate of change in Central Subfield Retinal Thickness (CSRT) | Rates will be assessed with the proportion of patients with changes. | Monthly, from baseline to Month 6 |
| Rate of change in Intra-Retinal Cystoid (IRCs) | Rates will be assessed with the proportion of patients with changes. | Monthly, from baseline to Month 6 |
| Rate of change in Pigment Epithelial Detachments (PEDs) | Rates will be assessed with the proportion of patients with changes. | Monthly, from baseline to Month 6 |
| Rate of Dry Retina | Rates will be assessed with the proportion of patients with changes. | Monthly, from baseline to Month 6 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |