Phase 4
Completed N=25
Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy
Nonproliferative Diabetic Retinopathy
Source: ClinicalTrials.gov NCT02834663 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: The Best Corrected Visual Acuity (BCVA) — 67.6; 76.36 letters — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Title of study:
Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR) with DME assessed by microaneurysm changes: A pilot study Objectives Diabetic retinopathy (DR) is a major cause of visual impairment. Anti-vascular endothelial growth factors have demonstrated therapeutic benefits in diabetic macular edema (DME). We aimed to prospectively analyze the effects of early intensive treatment using intravitreal ranibizumab (IVR) injections in nonproliferative diabetic retinopathy patients with macular edema.
Primary objective:
To investigate other efficacy endpoints including other visual acuity, anatomical change in mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.
Secondary objectives:
To compare microvascular changes assessed by microaneurysm counts and perifoveal non-perfusion area changes and safty in eyes of mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Best Corrected Visual Acuity (BCVA) |
67.6; 76.36 | <0.0001 sig |
| PRIMARY Central Macular Thickness(CMT) |
479.12; 369.12 | 0.0001 sig |
| SECONDARY The Total Number of Microaneurysm |
5.68; 1.60 | 0.001 sig |
| SECONDARY The Microaneurysm Formation Rate |
2.48; 0.96 | 0.0001 sig |
| SECONDARY The Microaneurysm Disappearance Rate |
4.40; 0.96 | 0.0001 sig |
| SECONDARY The Microaneurysm Turnover |
6.88; 1.92 | 0.0001 sig |
| SECONDARY Perifoveal Non-perfusion Area in FAG (mm²) |
2.517; 2.495 | 0.221 |
| SECONDARY Safety Parameters |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients (Male & female) ≥40 years of age
- Type 2 DM
- Best corrected visual acuity ≥ 20/200 (Snellen equivalent using Early Treatment Diabetic Retinopathy Study chart)
- central retinal thickness of ≥300 µm on optical coherence tomography
- nonproliferative diabetic retinopathy (NPDR) with diabetic macular edema
Exclusion Criteria
- proliferative diabetic retinopathy
- Vitreous hemorrhage
- previous history of vitreoretinal surgery, post-cataract operation status (≤4 months before participation in this study)
- prior treatment with anti-VEGF drugs, intraocular corticosteroids, and/or retinal laser application
- Uncontrolled hypertension.
- Uncontrolled glaucoma.
- If both eyes met the study inclusion criteria, the more severely affected eye was selected
Data sourced from ClinicalTrials.gov (NCT02834663). 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.