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This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 15 centers in the United States (US).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRX-101 | Experimental | Subjects randomized to IRX-101 will receive the investigational product, IRX-101. |
|
| 5% Povidone-iodine | Active Comparator | Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRX-101 | Drug | IRX-101 is a novel ocular anti-septic |
| |
| Providone-Iodine |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of new drug | Safety will be measured via slit lamp and fundoscopic examinations | 1-hour and 1-week post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean corneal fluorescein staining scores | Compare mean corneal fluorescein staining scores obtained after IVT in the IRX-101 and standard of care groups; corneal staining will be obtained using the validated Oxford Corneal Staining scale of 0 (no staining) to 5 (maximal staining) | Immediately following intraviteral injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Smith, MD | Founder | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Eye Surgeons, LLC | Greenwich | Connecticut | 06830 | United States | ||
| Mississippi Retina Associates |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Subjects will be randomized to IRX-101 or Providone-Iodine
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Treatment assignment will be unknown (or masked) to the study subjects, the evaluating physician, the Sponsor and its agents (with the exception of personnel performing randomization, unmasked drug accountability study monitors, and corporate compliance staff). The treating physician will be unmasked.
| Drug |
5% Providone-Iodine |
|
| Patient-reported post-injection pain scores |
Compare mean patient-reported post-injection pain scores 1-hour post-administration; pain will be assessed using the visual analog pain scale, a validated patient-reported outcome measure (questionnaire) for assessing patient's subjective pain and discomfort |
| 1-hour post-administration |
| Madison |
| Mississippi |
| 39110 |
| United States |
| Erie Retina Research, LLC | Erie | Pennsylvania | 16507 | United States |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | United States |
| Retina Consultants of Texas | Katy | Texas | 77494 | United States |
| Edward Wood, MD | Round Rock | Texas | 78681 | United States |
| Retina Associates of Utah | Salt Lake City | Utah | 84107 | United States |