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Trial record 1 of 1 for:    NCT01189461
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Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT01189461
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : September 6, 2013
Last Update Posted : September 6, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 23, 2010
First Posted Date  ICMJE August 26, 2010
Results First Submitted Date  ICMJE June 27, 2013
Results First Posted Date  ICMJE September 6, 2013
Last Update Posted Date September 6, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
  • Incidence of Ocular and Non-Ocular Adverse Events (AEs) [ Time Frame: Baseline up to 30 days after last dose ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Total number of participants who had ocular and non-ocular AEs was reported.
  • Mean Total Number of Injections [ Time Frame: Baseline up to Week 48 (End of treatment) ]
    Mean number of injections per participant was calculated as (number of injection administered per participant - 1)/duration of treatment. Mean number of injections administered for total participants was summarized.
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
The incidence of AEs (ocular and non-ocular). [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT01189461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
  • Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after last dose ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Total number of participants who had ocular and non-ocular SAEs was reported.
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment) [ Time Frame: Baseline, Week 48 (End of treatment) ]
    VA indicated sharpness or clarity of vision. BCVA assessed by early treatment diabetic retinopathy study chart using 4 meter (m), 1m distance, or if participant was able to count fingers, perceive hand motion or light. At 4m (>= 20 letters), VA score=number of letters correct plus 30 (credited for 30 letters at 1m); otherwise , VA score=number of letters read correctly at 1m plus number read at 4m (if any). If no letters were read correctly at 4m or 1m, VA score= 0, which were excluded from summary statistics calculation. BVCA score ranged: 0 (poor eyesight) to 78 (best eyesight).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
  • The incidence of SAEs both ocular and non-ocular. [ Time Frame: 1 year ]
  • Mean total number of injections per subject. [ Time Frame: 1 year ]
  • Mean changes in BCVA from baseline to end of treatment. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary 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.
Detailed Description Not 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 Date July 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 Countries Austria,   Germany,   Greece,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT01189461
Other Study ID Numbers  ICMJE A5751036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP