| ID | Type | Description | Link |
|---|---|---|---|
| AGN211745 |
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| Name | Class |
|---|---|
| Sirna Therapeutics Inc. | INDUSTRY |
The purpose of this study will be to assess the safety and tolerability and dose-limiting toxicity of a single intravitreal injection of Sirna-027 (AGN211745) and to assess the anatomical changes in the retina, changes in CNV, and changes in visual acuity. Escalation to the next dose cohort will be completed following minimum of 2 weeks follow-up. Patients will be monitored intensively for three months, and then followed-up for safety up to 24 months post-injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single intravitreal injection |
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| 2 | Experimental | Single intravitreal injection |
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| 3 | Experimental | Single intravitreal injection |
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| 4 | Experimental | Single intravitreal injection |
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| 5 | Experimental | Single intravitreal injection |
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| 6 | Experimental | Single intravitreal injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN211745 | Drug | 100microgram single intravitreal injection |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity using the Diabetic Retinopathy Study chart | Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24 | |
| IOP | Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore | Maryland | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20609706 | Derived | Kaiser PK, Symons RC, Shah SM, Quinlan EJ, Tabandeh H, Do DV, Reisen G, Lockridge JA, Short B, Guerciolini R, Nguyen QD; Sirna-027 Study Investigators. RNAi-based treatment for neovascular age-related macular degeneration by Sirna-027. Am J Ophthalmol. 2010 Jul;150(1):33-39.e2. doi: 10.1016/j.ajo.2010.02.006. |
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| AGN211745 | Drug | 200microgram single intravitreal injection |
|
|
| AGN211745 | Drug | 400microgram single intravitreal injection |
|
|
| AGN211745 | Drug | 800microgram single intravitreal injection |
|
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| AGN211745 | Drug | 1200microgram single intravitreal injection |
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| AGN211745 | Drug | 1600microgram single intravitreal injection |
|
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| OCT | Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84 |
| Fluorescein Angiography (FA) | Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24) |
| Cleveland |
| Ohio |
| United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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