Skip to main content
OpenTrials
Completed

NCT Number: NCT02131350

Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema

The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Macula Edema

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department ou Ophthalmology Shinshu University School of Medicine

Matsumoto, Nagano, 3908621, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • stable medication for the management of diabetes within 3 months
  • visual impairment due to focal or diffuse diabetic macula edema
  • decreased vision due to diabetic macula edema and not other causes

Exclusion criteria

  • concomitant conditions in the study eye that could prevent the improvement in VA on the study
  • active intraocular inflammation or infection in either eye
  • uncontrolled glaucoma in either eye
  • treatment with antiangiogenic drugs in the study eye within 3 months
  • history of stroke and uncontrolled hypertension

Treatment and study plan

Photocoagulation

Procedure

Photocoagulation include focal/grid laser and/or panretinal photocoagulation

ranibizumab

Drug

Primary outcomes

  1. best corrected visual acuity

    Time frame: every month, up to 36 months

    Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.

Sponsors and collaborators

Lead sponsor

Shinshu University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 6, 2014
Registry last updated
Sep 7, 2018

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.