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Completed

NCT Number: NCT01724385

Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).

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Key information

Conditions

Vitreous Hemorrhage Eye Diseases Eye Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Proliferative Diabetic Retinopathy

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

About this study

The investigators will carry out a prospective study in patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes will be treated with intravitreal injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. Re-injection will be done in non-clearing and recurrent VH.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with diabetes mellitus
  • proliferative diabetic retinopathy
  • prior complete panretinal photocoagulation
  • presented with new dense vitreous hemorrhage

Exclusion criteria

  • one-eyed patient
  • previous intraocular surgery
  • severe lens opacity precluding fundus examination
  • advance glaucoma
  • history of thromboembolic events such as myocardial infarction and cerebrovascular accident
  • uncontrolled systemic hypertension, systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg
  • known coagulation abnormalities or current use of anticoagulant medications other than aspirin
  • known allergies to any relevant drugs in this study
  • evidence of external ocular infection such as conjunctivitis and significant blepharitis.

Treatment and study plan

Intravitreal injection of bevacizumab

Drug

intravitreal injection of bevacizumab

Other names: Avastin

Primary outcomes

  1. The percentage of eyes that vitreous hemorrhage has been completely resolved

    Time frame: 12 months

    The patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes were treated with intravitreal bevacizumab injection. Complete ophthalmic examination and/or ocular ultrasonography were performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.

Secondary outcomes

  1. The change in best corrected visual acuity (BCVA) from baseline

    Time frame: 12 months

    The best corrected visual acuity (BCVA) was performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.

Other outcomes

  1. Numbers of injection

    Time frame: 12 months

    Numbers of intravitreous bevacizumab injection in a 12-month period

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy With New Dense Vitreous Hemorrhage After Full Panretinal Photocoagulation

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 9, 2012
Registry last updated
Apr 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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