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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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.
Kuopion Yliopistollinen sairaala
Kuopio, Finland
PHSOTEY / Silmätautien klinikka
Lahti, Finland
Hospital Naval Del Ferrol
Ferrol, A Coruña, Spain
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.
Time frame: 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.
Time frame: Baseline up to Week 48 (End of treatment)
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.
Time frame: Baseline up to 30 days after last dose
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).
Time frame: Baseline, Week 48 (End of treatment)
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Hospital Universitari de Girona Dr. Josep Trueta
Girona, Girona, Spain
Hospital Ntra. Sra. de La Esperanza
Santiago de Compostela, La Coruña, Spain
Hospital Universitario Clinico San Carlos
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain
Stockholms Ogonklinik
Stockholm, Sweden
Ogonkliniken, Centrallasarettet
Västerås, Sweden
...and 2 more locations