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

Phase 3

Completed

• Conditions: Anti- VGF Inhibitor; Diabetic Macular Edema; Diabetic Retinopathy
• Interventions: Drug: pegaptanib sodium

• Registration Number: NCT01189461
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Study Start: 2011-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-06
• Results First Submitted: 2013-06-27
• Results First Submitted QC: 2013-06-27
• Last Update Submitted: 2013-06-27
• Results First Posted: 2013-09-06
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pegaptanib sodium arm	pegaptanib sodium	all patients will receive pegaptanib sodium

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)	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).
Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)	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.

Trial Locations

Locations (12)

Hospital Universitari de Girona Dr. Josep Trueta; 🇪🇸 Girona, Spain

Ogonkliniken, Centrallasarettet; 🇸🇪 Vasteras, Sweden

Kings College Hospital; 🇬🇧 London, United Kingdom

Frimley Park Hospital; 🇬🇧 Frimley, Camberley, Surrey, United Kingdom

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

PHSOTEY / Silmätautien klinikka; 🇫🇮 Lahti, Finland

Hospital Universitari Sant Joan de Reus; 🇪🇸 Reus, Tarragona, Spain

Hospital Ntra. Sra. de La Esperanza; 🇪🇸 Santiago de Compostela, La Coruña, Spain

Hospital Universitario Clinico San Carlos; 🇪🇸 Madrid, Spain

Stockholms Ogonklinik; 🇸🇪 Stockholm, Sweden

Hospital Naval Del Ferrol; 🇪🇸 Ferrol, A Coruña, Spain

Kuopion Yliopistollinen sairaala; 🇫🇮 Kuopio, Finland