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The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD). The Epi-Rad90™ Ophthalmic System treats neovascularization of retinal tissue by means of a focal, directional delivery of radiation to the target tissues in the retina. Using standard vitreoretinal surgical techniques, the sealed radiation source is placed temporarily over the retinal lesion by means of a handheld medical device.
Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Epi-Rad90™ Ophthalmic System procedure + Lucentis |
|
| B | Active Comparator | Lucentis only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epi-Rad90™ Ophthalmic System | Device | A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline. Gain of 15 more letters of best correct visual acuity score compared to baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| No loss in ETDRS letters | 12 months | |
| Change in total lesion size and CNV size by fluorescein angiography | 12 months | |
| Number of rescue injections of Lucentis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pravin Dugel, MD | Retinal Consultants of Arizona | Principal Investigator |
| Jeffrey A Nau, MMS | NeoVista, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Phoenix | Arizona | 85014 | United States | ||
| Retina Center, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32844399 | Derived | Evans JR, Igwe C, Jackson TL, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 Aug 26;8(8):CD004004. doi: 10.1002/14651858.CD004004.pub4. |
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| ranibizumab | Drug | Lucentis injection administered monthly for the first 3 injections followed by quarterly injections |
|
|
| 12 months |
| Mean change in ETDRS visual acuity | 12 months |
| Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity. | 3 years |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Retina-Vitreous Associates Medical | Beverly Hills | California | 90211 | United States |
| Retinal Diagnostic Center | Campbell | California | 95008 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| UCSF Koret Vision Center | San Francisco | California | 94143 | United States |
| Retina Group of Florida | Fort Lauderdale | Florida | 33334 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Retina Institute of Hawaii | Honolulu | Hawaii | 96814 | United States |
| Paducah Retinal Center | Paducah | Kentucky | 42001 | United States |
| New England Eye Center-Tufts University | Boston | Massachusetts | 02111 | United States |
| Associated Retinal Consultants / William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Eye Foundation of Kansas City | Kansas City | Missouri | 64108 | United States |
| Charlotte Eye Ear Nose & Throat Associates | Charlotte | North Carolina | 28210 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Retina Research Unit of Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Tennessee Retina | Nashville | Tennessee | 37203 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Retina & Uveitis Consultants of Texas | San Antonio | Texas | 78240 | United States |
| Rocky Mountain Retina Consultants | Salt Lake City | Utah | 84107 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Augenklinik Graz | Graz | Austria |
| Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR | Leipzig | 04103 | Germany |
| Universitätsklinik und polyklinik für Augenkranke | Würzburg | 97080 | Germany |
| Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital | Belfast | Ireland |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Oftalmo Salud Eye Institute | Lima | Peru |
| Institutio de Microcirugia Ocular-Barcelona | Barcelona | Spain |
| University of Geneva | Geneva | 1211GE14 | Switzerland |
| Kings College Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| 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 |
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