NCT01189461

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

Geographic Reach
4 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 6, 2013

Completed
Last Updated

September 6, 2013

Status Verified

June 1, 2013

Enrollment Period

1.5 years

First QC Date

July 23, 2010

Results QC Date

June 27, 2013

Last Update Submit

June 27, 2013

Conditions

Anti- VGF InhibitorDiabetic Macular EdemaDiabetic Retinopathy

Keywords

pegaptanib sodiumdiabetic macular edema

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline up to 30 days after last dose

  • 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.

    Baseline up to Week 48 (End of treatment)

Secondary Outcomes (2)

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

    Baseline up to 30 days after last dose

  • Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)

    Baseline, Week 48 (End of treatment)

Study Arms (1)

pegaptanib sodium arm

EXPERIMENTAL

all patients will receive pegaptanib sodium

Drug: pegaptanib sodium

Interventions

pegaptanib sodiumDRUG

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.

pegaptanib sodium arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Kuopion Yliopistollinen sairaala

Kuopio, 70210, Finland

Location

PHSOTEY / Silmätautien klinikka

Lahti, 15850, Finland

Location

Hospital Naval Del Ferrol

Ferrol, A Coruña, 15405, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta

Girona, Girona, 17007, Spain

Location

Hospital Ntra. Sra. de La Esperanza

Santiago de Compostela, La Coruña, 15705, Spain

Location

Hospital Universitario Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, 43204, Spain

Location

Stockholms Ogonklinik

Stockholm, 114 86, Sweden

Location

Ogonkliniken, Centrallasarettet

Västerås, 721 89, Sweden

Location

Frimley Park Hospital

Frimley, Camberley, Surrey, GU15 3UW, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25187694DERIVED

Related Links

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2010

First Posted

August 26, 2010

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 6, 2013

Results First Posted

September 6, 2013

Record last verified: 2013-06

Locations

ES(6)SE(2)GB(2)FI(2)