pegaptanib sodium injection
Drug0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
Other names: Macugen
NCT Number: NCT01573572
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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Notify Me50 year and older
All sexes
Interventional
Phase 4
Marietta Eye Clinic, Murrieta, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
Other names: Macugen
Time frame: 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.
Bausch & Lomb Incorporated
Industry
A Phase IV, Open Label, Multi-center Study to Assess the Effect of Intravitreal Injections of Macugen (Pegaptanib Sodium Injection) Administered Every 6 Weeks for 48 Weeks on the Corneal Endothelium.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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