Phase 3
Completed N=243
A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema
macular edema · Diabetic Mellitus · Retinal Disease
Source: ClinicalTrials.gov NCT01100307 ↗
Enrolled (actual)
243
Serious AEs
9.6%
Results posted
Jul 2013
Primary outcomePrimary: Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase — 25; 6 Participants — p=0.0003
Summary
The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase |
25; 6 | 0.0003 sig |
| SECONDARY Change From Baseline in Visual Acuity (VA): Double Masked Phase |
2.7; 0.2; 3.2; -0.6; 2.8; 0.1 | 0.0006 sig |
| SECONDARY Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase |
3; 1; 0; 1 | — |
| SECONDARY Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase |
28; 15 | — |
| SECONDARY Change From Baseline in Visual Acuity (VA): Open Phase |
3.5; -0.1; 4.4; 0.6; 4.3; 0.3 | — |
| SECONDARY Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase |
3; 3; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Type I, or Type II diabetic subjects
- Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive
Exclusion Criteria
- Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline eyes in which PRP is needed now or is likely to be needed within the next 9 months
- HbA1C level >12% or recent signs of uncontrolled diabetes
- Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy
Data sourced from ClinicalTrials.gov (NCT01100307). 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.