Clinical trial NCT01189461: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anti- VGF Inhibitor
Diabetic Macular Edema
Diabetic Retinopathy
Keywords: pegaptanib sodium
diabetic macular edema
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of Ocular and Non-Ocular Adverse Events (AEs)
timeFrame: Baseline up to 30 days after last dose
measure: Mean Total Number of Injections
timeFrame: Baseline up to Week 48 (End of treatment)
Secondary outcomes:
measure: Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)
timeFrame: Baseline up to 30 days after last dose
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)
timeFrame: Baseline, Week 48 (End of treatment)
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen sairaala
city: Lahti
country: Finland
facility: PHSOTEY / Silmätautien klinikka
city: Ferrol
country: Spain
facility: Hospital Naval Del Ferrol
state: A Coruña
city: Santiago de Compostela
country: Spain
facility: Hospital Ntra. Sra. de La Esperanza
state: La Coruña
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Stockholm
country: Sweden
facility: Stockholms Ogonklinik
city: Vasteras
country: Sweden
facility: Ogonkliniken, Centrallasarettet
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
state: Camberley, Surrey
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.