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Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema

Last updated on February 23, 2019

FOR MORE INFORMATION
Study Location
Kuopion Yliopistollinen sairaala
Kuopio, , 70210 Finland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Anti- VGF Inhibitor, Diabetic Macular Edema, Diabetic Retinopathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

- Subjects with documented clinical diagnosis of diabetic macular edema (DME) with
proliferative or non proliferative diabetic retinopathy.

- Subjects, who according to the clinical assessment of the investigator, may benefit
from anti-VEGF therapy including those subjects who were participating in the A5751013
study and who, in the investigator's opinion, may benefit from continued pegaptanib
sodium therapy.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Eyes with prior scatter (panretinal) photocoagulation within 4 months prior to
baseline or anticipated scatter (panretinal) photocoagulation within the next 6
months.

- Presence of any abnormality that is likely to confound assessment of visual acuity
improvement in eyes in which macular edema resolves, or improves, such as
non-perfusion for >1 disc area involving the foveal avascular zone (FAZ - involving 2
or more quadrants centered around the foveal avascular zone), epiretinal membrane
associated with signs of contraction and/or significant opacification (i.e. striae
within 1 disc diameter of the foveal center), or presence of chorioretinal atrophy
involving the center of the macula.

- Vitreomacular traction determined clinically and/or by optical coherence tomography
(OCT), which, in the investigator's opinion, contributes to the macular edema (or
causes associated foveal detachment), and would preclude improvement with pegaptanib
sodium.

- Any other cause of macular edema such as vitreous extension, or entrapment to anterior
segment wound, or any retinal vein occlusion involving the macula.

NCT01189461
Pfizer
Completed
Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Anti- VGF Inhibitor, Diabetic Macular Edema, Diabetic Retinopathy
NCT01189461
All Genders
18+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now