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

Last updated on November 14, 2019

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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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Descriptive Information
Brief Title  ICMJE Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema
Official Title  ICMJE An Open Label, One Year, Non-Comparative Study To Evaluate The Safety And Tolerability Of Intravitreous Pegaptanib Sodium In Patients With Diabetic Macular Edema
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anti- VGF Inhibitor
  • Diabetic Macular Edema
  • Diabetic Retinopathy
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: pegaptanib sodium arm
all patients will receive pegaptanib sodium
Intervention: Drug: pegaptanib sodium
Publications *Sivaprasad S, Browning RC, Starita C. An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema. Clin Ophthalmol. 2014 Aug 21;8:1565-71. doi: 10.2147/OPTH.S68498. eCollection 2014.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2012)
46
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2010)
500
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion DateJuly 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   Spain,   Sweden,   United Kingdom
Removed Location CountriesAustria,   Germany,   Greece,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT01189461
Other Study ID Numbers  ICMJE A5751036
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2013

ICMJE     Data element required by the

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

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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