Phase 3
Completed N=317
A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.
Macular Edema Associated With Diabetes Mellitus
Source: ClinicalTrials.gov NCT00605280 ↗
Enrolled (actual)
317
Serious AEs
20.4%
Results posted
Mar 2011
Primary outcomePrimary: Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year — 49; 25 Participants — p=0.0047
Summary
The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year |
49; 25 | 0.0047 sig |
| SECONDARY Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years |
51; 37 | 0.1904 |
| SECONDARY Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year |
22; 13 | 0.2466 |
| SECONDARY Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years |
30; 18 | 0.1388 |
| SECONDARY Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year |
4; 12 | 0.0468 sig |
| SECONDARY Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year |
10; 3 | 0.1124 |
| SECONDARY Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years |
6; 13 | 0.1788 |
| SECONDARY Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years |
17; 3 | 0.0048 sig |
| SECONDARY Change From Baseline in Mean VA Score at 1 Year |
57.0; 57.5; 5.2; 1.2 | 0.0040 sig |
| SECONDARY Change From Baseline in Mean VA Score at 2 Years |
57.0; 57.4; 6.2; 1.7 | 0.0011 sig |
| SECONDARY Number of Participants Requiring Focal or Grid Laser Treatment During Year 1 |
31; 53 | 0.0023 sig |
| SECONDARY Number of Participants Requiring Focal or Grid Laser Treatment During Year 2 |
34; 57 | 0.0008 sig |
Eligibility Criteria
Inclusion Criteria
- macular edema associated with diabetes
- visual acuity between 20/50 and 20/200
Exclusion Criteria
- recent laser therapy in the eye
- recent signs of uncontrolled diabetes
- blood pressure worse than 160/100
- severe cardiac disease
Data sourced from ClinicalTrials.gov (NCT00605280). 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.