Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intravitreal Injections of Macugen
|
Drug: pegaptanib sodium injection
0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Mean Endothelial Cell Density [Baseline, Week 54]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects of either gender aged > or = to 50 years diagnosed with subfoveal neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, or Retinal Vein Occlusion.
-
Best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/20 and 20/400 using a Snellen chart.
-
Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to study entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication.
-
Provide written informed consent.
-
Ability to return for all study visits.
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
-
Unilateral ocular blunt trauma within one year of enrollment and no greater than 5% difference in central endothelial cell density between the 2 eyes.
-
intraocular surgery (cataract surgery and surgery for glaucoma without tube shunt or mini-shunt) within one year of enrollment.
-
Anterior segment laser surgery (laser trabeculoplasty) performed within one year of enrollment.
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Glaucoma tube-shunt surgery
-
Previous history of corneal transplant in the study or non-study eye
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Presence of vitreous macular traction
-
Previous therapeutic radiation in the region of the study eye
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Any treatment with an investigational agent in the past 30 days for any condition
-
Known serious allergies to the components of pegaptanib sodium formulation
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Marietta Eye Clinic | Murrieta | California | United States | 30060 |
| 2 | Wolfe Eye Clinic | Marshalltown | Iowa | United States | 50158 |
| 3 | Associates in Ophthalmology | West Mifflin | Pennsylvania | United States | 15122 |
| 4 | Valley Retina Institute | Harlingen | Texas | United States | 78550 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Mandeep Kaur, M.D., Valeant Pharmaceuticals NA
Study Documents (Full-Text)
More Information
Publications
None provided.- EOP 1024
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Intravitreal Injections of Macugen |
|---|---|
| Arm/Group Description | pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks |
| Period Title: Overall Study | |
| STARTED | 131 |
| COMPLETED | 103 |
| NOT COMPLETED | 28 |
Baseline Characteristics
| Arm/Group Title | Intravitreal Injections of Macugen |
|---|---|
| Arm/Group Description | pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks |
| Overall Participants | 131 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
71.0
(10.17)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
76
58%
|
| Male |
55
42%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
3
2.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
7
5.3%
|
| White |
81
61.8%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
40
30.5%
|
| Designated eye (Count of Participants) | |
| Right eye |
69
52.7%
|
| Left eye |
62
47.3%
|
Outcome Measures
| Title | Change From Baseline in Mean Endothelial Cell Density |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with cell density assessments at both baseline and Week 54. |
| Arm/Group Title | Intravitreal Injections of Macugen |
|---|---|
| Arm/Group Description | pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks |
| Measure Participants | 87 |
| Mean (Standard Deviation) [cells/millimeter squared] |
-35.86
(175.544)
|
Adverse Events
| Time Frame | 54 weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Intravitreal Injections of Macugen | |
| Arm/Group Description | pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks | |
All Cause Mortality |
||
| Intravitreal Injections of Macugen | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/131 (3.1%) | |
Serious Adverse Events |
||
| Intravitreal Injections of Macugen | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/131 (9.2%) | |
| Cardiac disorders | ||
| Cardiac failure congestive | 2/131 (1.5%) | |
| Myocardial infarction | 2/131 (1.5%) | |
| Bradycardia | 1/131 (0.8%) | |
| Cardiac arrest | 1/131 (0.8%) | |
| Eye disorders | ||
| Glaucoma | 1/131 (0.8%) | |
| Visual acuity reduced | 1/131 (0.8%) | |
| Gastrointestinal disorders | ||
| Erosive oesophagitis | 1/131 (0.8%) | |
| Gastritis | 1/131 (0.8%) | |
| Pancreatic carcinoma | 1/131 (0.8%) | |
| General disorders | ||
| Chest pain | 2/131 (1.5%) | |
| Infections and infestations | ||
| Pneumonia | 1/131 (0.8%) | |
| Investigations | ||
| Hypernatraemia | 1/131 (0.8%) | |
| Metabolism and nutrition disorders | ||
| Diabetes mellitus inadequate control | 1/131 (0.8%) | |
| Psychiatric disorders | ||
| Suicidal ideation | 1/131 (0.8%) | |
| Renal and urinary disorders | ||
| Urinary tract infection | 1/131 (0.8%) | |
| Acute kidney injury | 1/131 (0.8%) | |
| Vascular disorders | ||
| Blood pressure inadequately controlled | 2/131 (1.5%) | |
| Cerebrovascular accident | 1/131 (0.8%) | |
Other (Not Including Serious) Adverse Events |
||
| Intravitreal Injections of Macugen | ||
| Affected / at Risk (%) | # Events | |
| Total | 19/131 (14.5%) | |
| Eye disorders | ||
| Eye pain | 10/131 (7.6%) | |
| Conjunctival haemorrhage | 9/131 (6.9%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Contact sponsor directly for details.
Results Point of Contact
| Name/Title | Study Manager |
|---|---|
| Organization | Bausch Health |
| Phone | 908-242-8287 |
| sandra.narain@bauschhealth.com |
- EOP 1024