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

Primary Purpose

Anti- VGF Inhibitor, Diabetic Macular Edema, Diabetic Retinopathy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pegaptanib sodium
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anti- VGF Inhibitor focused on measuring pegaptanib sodium, diabetic macular edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kuopion Yliopistollinen sairaala
  • PHSOTEY / Silmätautien klinikka
  • Hospital Naval Del Ferrol
  • Hospital Ntra. Sra. de La Esperanza
  • Hospital Universitari Sant Joan de Reus
  • Hospital Universitari de Girona Dr. Josep Trueta
  • Hospital Universitario Clinico San Carlos
  • Hospital Universitario 12 de Octubre
  • Stockholms Ogonklinik
  • Ogonkliniken, Centrallasarettet
  • Frimley Park Hospital
  • Kings College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pegaptanib sodium arm

Arm Description

all patients will receive pegaptanib sodium

Outcomes

Primary Outcome Measures

Incidence of Ocular and Non-Ocular Adverse Events (AEs)
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
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.

Secondary Outcome Measures

Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)
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)
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).

Full Information

First Posted
July 23, 2010
Last Updated
June 27, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01189461
Brief Title
Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema
Official Title
An Open Label, One Year, Non-Comparative Study To Evaluate The Safety And Tolerability Of Intravitreous Pegaptanib Sodium In Patients With Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti- VGF Inhibitor, Diabetic Macular Edema, Diabetic Retinopathy
Keywords
pegaptanib sodium, diabetic macular edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pegaptanib sodium arm
Arm Type
Experimental
Arm Description
all patients will receive pegaptanib sodium
Intervention Type
Drug
Intervention Name(s)
pegaptanib sodium
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Ocular and Non-Ocular Adverse Events (AEs)
Description
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.
Time Frame
Baseline up to 30 days after last dose
Title
Mean Total Number of Injections
Description
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.
Time Frame
Baseline up to Week 48 (End of treatment)
Secondary Outcome Measure Information:
Title
Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to 30 days after last dose
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)
Description
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).
Time Frame
Baseline, Week 48 (End of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Kuopion Yliopistollinen sairaala
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
PHSOTEY / Silmätautien klinikka
City
Lahti
ZIP/Postal Code
15850
Country
Finland
Facility Name
Hospital Naval Del Ferrol
City
Ferrol
State/Province
A Coruña
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hospital Ntra. Sra. de La Esperanza
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15705
Country
Spain
Facility Name
Hospital Universitari Sant Joan de Reus
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
Facility Name
Hospital Universitari de Girona Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Stockholms Ogonklinik
City
Stockholm
ZIP/Postal Code
114 86
Country
Sweden
Facility Name
Ogonkliniken, Centrallasarettet
City
Vasteras
ZIP/Postal Code
721 89
Country
Sweden
Facility Name
Frimley Park Hospital
City
Frimley
State/Province
Camberley, Surrey
ZIP/Postal Code
GU15 3UW
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25187694
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5751036&StudyName=Study%20To%20Evaluate%20Safety%20And%20Tolerability%20Of%20Pegaptanib%20Sodium%20In%20Patients%20With%20Diabetic%20Macular%20Edema
Description
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Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema

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