Phase 3
Completed N=46
Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema
Anti- VGF Inhibitor · Diabetic Macular Edema · Diabetic Retinopathy
Source: ClinicalTrials.gov NCT01189461 ↗
Enrolled (actual)
46
Serious AEs
6.5%
Results posted
Sep 2013
Primary outcomePrimary: Incidence of Ocular and Non-Ocular Adverse Events (AEs) — 10; 8 participants
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.
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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. Informational only — not medical advice.