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This study was conducted because the FDA requested clinical information on potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium from a 1-year (minimum) post-approval clinical study to support that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal Injections of Macugen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegaptanib sodium injection | Drug | 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Endothelial Cell Density | The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density change from baseline. This is to evaluate that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen. | Baseline, Week 54 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will not be eligible for the study if subjects cannot attend all study-required visits, or if any of the following criteria are present
Any of the following underlying diseases including:1. History or evidence of severe cardiac disease(e.g. NYHA Functional Class III or IV - see Appendix 2), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrhythmias requiring ongoing treatment 7. History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation 8. History or evidence of clinically significant impaired renal or hepatic function 8. Stroke (within 12 months of study entry) 9. Any major surgical procedure within one month of study entry 10. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity. Subjects should not be entered if there is likelihood that they will require cataract or glaucoma surgery in either eye during the study treatment and follow-up period.
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| Name | Affiliation | Role |
|---|---|---|
| Mandeep Kaur, M.D. | Valeant Pharmaceuticals NA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marietta Eye Clinic | Murrieta | California | 30060 | United States | ||
| Wolfe Eye Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravitreal Injections of Macugen | pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravitreal Injections of Macugen | pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Mean Endothelial Cell Density | The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density change from baseline. This is to evaluate that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen. | Participants with cell density assessments at both baseline and Week 54. | Posted | Mean | Standard Deviation | cells/millimeter squared | Baseline, Week 54 |
|
|
54 weeks
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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 | Intravitreal Injections of Macugen | pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | Bausch Health | 908-242-8287 | sandra.narain@bauschhealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2018 | Sep 19, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
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| ID | Term |
|---|---|
| C495058 | pegaptanib |
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| Marshalltown |
| Iowa |
| 50158 |
| United States |
| Associates in Ophthalmology | West Mifflin | Pennsylvania | 15122 | United States |
| Valley Retina Institute | Harlingen | Texas | 78550 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Designated eye | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 4 |
| 131 |
| 12 |
| 131 |
| 19 |
| 131 |
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Hypernatraemia | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pancreatic carcinoma | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Cerebrovascular accident | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
|
Contact sponsor directly for details.
| D013927 |
| Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |