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This study will determine whether quarterly injections of Ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration (AMD).
This is a multicenter, prospectively randomized, masked and controlled, interventional investigator sponsored phase I/II study of subjects with high-risk nonexudative age-related macular degeneration (AMD) treated with intravitreal ranibizumab quarterly for prophylaxis of conversion to exudative age-related macular degeneration.
The objective of this study is to investigate the safety and efficacy of prophylactic anti-vascular endothelial growth factor (VEGF) therapy with ranibizumab to prevent the development of exudative AMD in eyes with high-risk nonexudative AMD. In addition, baseline characteristics of high-risk eyes (fundus features, optical coherence tomography (OCT) parameters and genetic profile) will be evaluated to determine their predictive value in conversion to exudative AMD. The effect of ranibizumab on the atrophic component of AMD will also be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | No Intervention | Sham Injection | |
| Quarterly Ranibizumab 0.5mg | Active Comparator | Quarterly intravitreal injection of 0.5mg ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 0.5mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of exudative AMD | Development of choroidal neovascularization (conversion) defined by the presence of leakage on fluorescein angiography (FA) and fluid within or below the retina or below the retinal pigment epithelium seen on spectral-domain optical coherence tomography (SD-OCT) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Vision change | Change in best-corrected visual acuity (BCVA) from baseline at 12 and 24 months | 2 years |
| Vision loss | Proportion of eyes losing < 5, 10, and 15 letters on EDTRS chart at 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maziar Lalezary, MD | Southern California Desert Retina Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States | ||
| Southern California Desert Retina Consultants |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 24, 2023 | |
| Reset | Oct 20, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 24, 2023 | Oct 20, 2023 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D006009 | Glycogen Storage Disease Type II |
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020140 | Lysosomal Storage Diseases, Nervous System |
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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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| 2 years |
| Number of injections | Number of injections required in eyes that convert from dry to wet AMD during the study period | 2 years |
| Baseline predictive factors | Baseline demographic, genetic and ocular characteristics predictive of development of wet AMD | 2 years |
| Development of geographic atrophy (GA) | Development of geographic atrophy (GA) as detected by fundus photography (FP) and/or fundus autofluorescence (AF). | 2 years |
| Ocular adverse events | Incidence and severity of ocular adverse events, as identified by eye examination and imaging | 2 years |
| Systemic adverse events | Incidence and severity of other adverse events, as identified by physical examination or subject reporting. | 2 years |
| Palm Desert |
| California |
| 92211 |
| United States |
| Elman Retina | Baltimore | Maryland | 21237 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006008 | Glycogen Storage Disease |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |