Mode
Text Size
Log in / Sign up
Phase 3 N=46 Treatment

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

Anti- VGF Inhibitor · Diabetic Macular Edema · Diabetic Retinopathy

Enrolled (actual)
46
Serious AEs
6.5%
Results posted
Sep 2013
Primary outcome: Primary: Incidence of Ocular and Non-Ocular Adverse Events (AEs) — 10; 8 participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
pegaptanib sodium (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Pfizer
Primary completion
Jul 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Ocular and Non-Ocular Adverse Events (AEs)
10; 8
PRIMARY
Mean Total Number of Injections
3.24
SECONDARY
Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)
0; 3
SECONDARY
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)
58.93; 2.21

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01189461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search