Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to use in home technology to reduce the burden of in office visits and injections.
Without frequent measurement of vision to monitor disease progression some people may be under-treated, while others over-treated. Under-treatment can lead to severe and irreversible disease progression and associated loss of vision. Over-treatment is expensive, uncomfortable and potentially increases the risk of complications. A self-monitoring device such as DigiSight can help subjects keep close control of their treatment, but alleviate the burden of in office monitoring visits. A decreased number of office visits in combination with the home self-monitoring may provide an effective alternative dosing regimen, allowing the physician and subject to closely track the disease progression and treatment effect without the demands of monthly or frequent visits to the office.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucentis every 4 weeks | Active Comparator | Lucentis 0.5mg administered intravitreally every four weeks for 12 months |
|
| Lucentis every 12 weeks | Active Comparator | Lucentis 0.5mg administered intravitreally every 12 weeks |
|
| Treat and extend | Experimental | Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucentis (Treat and extend) | Drug | Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinoptahy Study (ETDRS) eye chart at a starting test distance of 4 meters, at Months 3, 6, 9 and 12 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Central foveal thickness | Central foveal thickness as determined by Spectral Domain-Ocular Coherence Tomography (SD-OCT). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of office visits needed | Number of office visits completed for patients on Arm C (treat-and-extend arm), compared to those on Arms A and B | 12 months |
| Number of required injections | Number of Lucentis® injections administered to patients in Arm C, compared to those on Arms A and B |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pravin U Dugel, MD | Retinal Consultants of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Gilbert | Arizona | 85296 | United States | ||
| Retinal Consultants of Arizona |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 25, 2018 | |
| Reset | Oct 26, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lucentis every 4 weeks | Drug | Lucentis 0.5mg administered intravitreally every four weeks for 12 months |
|
| Lucentis every 12 weeks | Drug | Lucentis 0.5mg administered intravitreally every twelve weeks for 12 months |
|
| 12 months |
| Mesa |
| Arizona |
| 85210 |
| United States |
| Retinal Consultants of Arizona | Peoria | Arizona | 85381 | United States |
| Retinal Consultants of Arizona | Phoenix | Arizona | 85014 | United States |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 25, 2018 | Oct 26, 2018 |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D003033 | Coal Tar |
| 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 |
| D013638 | Tars |
| D045424 | Complex Mixtures |
Not provided
Not provided