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The study was terminated early due to company decision (non-safety related).
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This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN 211745 Solution 1000 ug | Experimental | AGN 211745 Solution 1000 ug |
|
| AGN 211745 Solution 300 ug | Experimental | AGN 211745 Solution 300 ug |
|
| AGN 211745 Solution 100 ug | Experimental | AGN 211745 Solution 100 ug |
|
| Ranibizumab 500 ug | Active Comparator | Ranibizumab 500 ug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN 211745 | Drug | AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3 | Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3 | Lesion size as assessed by FA and photography at month 3. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. |
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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 |
|---|---|---|---|---|---|---|
| Houston | Texas | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN 211745 Solution 1000 ug | AGN 211745 Solution 1000 ug |
| FG001 | AGN 211745 Solution 300 ug | AGN 211745 Solution 300 ug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AGN 211745 | Drug | AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2 |
|
|
| AGN 211745 | Drug | AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2 |
|
|
| Ranibizumab 500µg | Drug | Ranibizumab 500µg injections at Day 1, Month 1, Month 2 |
|
|
| Month 3 |
| Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3 | Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision. | Month 3 |
| Visual Functioning Questionnaire (VFQ) at Month 3 | Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed. | Month 3 |
| Time to Treatment With Standard of Care at Month 6 | Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred. | Month 6 |
| Sydney |
| New South Wales |
| Australia |
| Makati | Philippines |
| FG002 | AGN 211745 Solution 100 ug | AGN 211745 Solution 100 ug |
| FG003 | Ranibizumab 500 ug | Ranibizumab 500 ug |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN 211745 Solution 1000 ug | AGN 211745 Solution 1000 ug |
| BG001 | AGN 211745 Solution 300 ug | AGN 211745 Solution 300 ug |
| BG002 | AGN 211745 Solution 100 ug | AGN 211745 Solution 100 ug |
| BG003 | Ranibizumab 500 ug | Ranibizumab 500 ug |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3 | Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. | Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized). | Posted | Number | Percentage of Patients | Month 3 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3 | Lesion size as assessed by FA and photography at month 3. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. | Intent-To-Treat. The ITT population included all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Millimeters squared (mm^2) | Month 3 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3 | Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision. | Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Microns | Month 3 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Visual Functioning Questionnaire (VFQ) at Month 3 | Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed. | Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized). Data for this outcome measure were not analyzed as the study was terminated early. | Posted | Month 3 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment With Standard of Care at Month 6 | Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred. | Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized). | Posted | Median | 95% Confidence Interval | Number of Days | Month 6 |
|
|
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The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AGN 211745 Solution 1000 ug | AGN 211745 Solution 1000 ug | 4 | 34 | 29 | 34 | ||
| EG001 | AGN 211745 Solution 300 ug | AGN 211745 Solution 300 ug | 3 | 35 | 26 | 35 | ||
| EG002 | AGN 211745 Solution 100 ug | AGN 211745 Solution 100 ug | 3 | 35 | 28 | 35 | ||
| EG003 | Ranibizumab 500 ug | Ranibizumab 500 ug | 9 | 34 | 24 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Biliary tract disorder | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Herpes zoster ophthalmic | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Lip neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anterior chamber cell | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Conjunctival oedema | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Detachment of retinal pigment | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Retinal neovascularization | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Retinal exudates | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anterior chamber flare | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Retinal oedema | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Retinal pigment epitheliopathy | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
The study was terminated early due to a company decision (non-safety related). Because the study was terminated early, data for certain outcome measures (ie, "Visual Functioning Questionnaire [VFQ] at Month 3") were not analyzed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008268 | Macular Degeneration |
| 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 |
| D012162 | Retinal Degeneration |
| D012164 | Retinal 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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| >=65 years |
|
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
Ranibizumab 500 ug |
|
|
| Units | Counts |
|---|
| Participants |
|
| Participants |
|
|