---
title: Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema
nct_id: NCT01487629
overall_status: UNKNOWN
phase: PHASE2
sponsor: University of Sao Paulo
study_type: INTERVENTIONAL
primary_condition: Diabetic Retinopathy
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01487629.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01487629"
ct_last_update_post_date: 2011-12-13
last_seen_at: "2026-05-12T07:10:10.423Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

**Official Title:** Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema

**NCT ID:** [NCT01487629](https://clinicaltrials.gov/study/NCT01487629)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 53
- **Lead Sponsor:** University of Sao Paulo
- **Collaborators:** Fundação de Amparo à Pesquisa do Estado de São Paulo
- **Conditions:** Diabetic Retinopathy, Macular Edema
- **Start Date:** 2010-04
- **Completion Date:** 2012-09
- **CT.gov Last Update:** 2011-12-13

## Brief Summary

The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Center-involving Diabetic macular edema unresponsive to LASER therapy performed at least 3 moths prior to inclusion;
* Best corrected visual acuity equal or worse than 20/40 and better than 20/800;
* Central subfield macular thickness greater than 300 µm

Exclusion Criteria:

* Aphakia
* High-risk proliferative diabetic retinopathy
* Previous treatment for DME in the past three months
```

## Arms

- **Bevacizumab** (EXPERIMENTAL) — Treatment of macular edema with intravitreal Bevacizumab
- **Ranibizumab** (EXPERIMENTAL) — Treatment of macular edema with intravitreal Ranibizumab

## Interventions

- **Bevacizumab** (DRUG) — Bevacizumab, 1.5 mg, intravitreal, throughout the study
- **Ranibizumab** (DRUG) — Ranibizumab, 0.5 mg, intravitreal, throughout the study

## Primary Outcomes

- **Central subfield macular thickness (CSFT) change** _(time frame: Monthly from baseline to Week 48)_ — Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)

## Secondary Outcomes

- **Best-corrected visual acuity change** _(time frame: Monthly from baseline to week 48)_

## Locations (1)

- Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP, Ribeirão Preto, São Paulo, Brazil

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.clinics hospital of ribeirão preto, school of medicine of ribeirão preto, usp|ribeirão preto|são paulo|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01487629.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01487629*  
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