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The addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting VEGF addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac + Ranibizumab | Experimental | 3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID |
|
| Ranibizumab Alone | Active Comparator | 3 monthly ranibizumab, then as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac + Ranibizumab | Drug | 3 monthly ranibizumab, then as needed Ketorolac TID |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| mean change in central macular thickness | 12 months | |
| mean number of intravitreal injections over the 12-month period | 12 months | |
| adverse ocular events at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Russo, MD | University of Brescia, Italy | Principal Investigator |
| Luisa Delcassi, MD | University of Brescia, Italy | Study Chair |
| Francesco Semeraro, Professor | University of Brescia, Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spedali Civili di Brescia | Brescia | BS | 25123 | Italy |
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ranibizumab | Drug | 3 monthly ranibizumab, then as needed |
|
| 12 months |
| D015862 |
| Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| 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 |