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

Last updated on May 10, 2018

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.
Show details

- 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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Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema
An Open Label, One Year, Non-Comparative Study To Evaluate The Safety And Tolerability Of Intravitreous Pegaptanib Sodium In Patients With Diabetic Macular Edema
This study will asses sthe safety of pegaptanib sodium in patients with diabetic macular edema. The hypothesis is that pegaptanib is safe and efficacious in patients with diabetic macular edema.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Anti- VGF Inhibitor
  • Diabetic Macular Edema
  • Diabetic Retinopathy
Drug: pegaptanib sodium
Upon enrollment, all subjects will be treated in the study eye with pegaptanib sodium 0.3 mg at the investigators' discretion based on visual acuity assessment up to a maximum of 48 weeks. The minimum dosing interval between injections will be at least 6 weeks.
Experimental: pegaptanib sodium arm
all patients will receive pegaptanib sodium
Intervention: Drug: pegaptanib sodium
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
July 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Spain,   Sweden,   United Kingdom
Austria,   Germany,   Greece,   Netherlands
 
NCT01189461
A5751036
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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