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Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium

NCT01573572 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2021-01-08

Study results available
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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.

Conditions

Interventions

DRUG

pegaptanib sodium injection

0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Mandeep Kaur, M.D. · Valeant Pharmaceuticals NA

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-22
Primary Completion
2019-11-14
Completion
2019-11-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01573572 on ClinicalTrials.gov