Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema (ReCaLL)

February 21, 2017 updated by: GWT-TUD GmbH

Evaluation of an Additional Therapeutic Approach to Diabetic Macular Edema by Combining Standard Therapy (Intravitreal Injection of a VEGF-inhibitor) With Micropulse Diode Laser Treatment in a Randomized, Controlled Proof of Concept Study

The primary objective of this study is to evaluate if a combination therapy with micropulse diode laser treatment shows non inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Chemnitz, Germany, 09116
        • Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of non-ischemic diabetic macular edema with resulting reduction in visual functionality by determination of best corrected visual acuity (BCVA), ophthalmologic investigation, SD-OCT, FAG and anamnesis
  • BCVA between 0.05 and 0.6 or retinal thickness > 300 µm determined by SD-OCT
  • The informed consent form must be signed before any study specific tests or procedures are done
  • Confirmation of the subject's health insurance coverage prior to the first screening visit
  • Age at least 18 years (inclusive) at the first screening visit
  • Ability to understand and follow study-related instructions

Exclusion Criteria:

  • Severe ischemic maculopathy of the study eye
  • Active neovascularization of iris or retina in the study eye
  • History of intravitreal injection of VEGF-inhibitor or steroids in study eye within the last 3 month
  • Pathologies of the anterior segment of the study eye with reduced visual acuity (e.g. corneal opacification, advanced cataract)
  • Advanced glaucoma with central defects of the visual field in study eye
  • Retinal pathologies with reduced visus (e.g. central scars, age related macular degeneration) in study eye
  • Retinal vascular occlusion in medical history of study eye
  • Active or suspected ocular or periocular infections
  • Active intraocular inflammation in study eye
  • Intraocular surgery of study eye within the last 6 months
  • Laser therapy of study eye within the last 6 months
  • Systemic steroid therapy within the last 3 month
  • HbA1c >10%
  • Systolic blood pressure above 170 mmHg and diastolic blood pressure above 110 mmHg (after at least 3 min in supine position)
  • Pregnant or breast-feeding woman and woman without adequate method of contraception.
  • Known hypersensitivity to the active substance or to any of the excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Group
Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC
Drug: ranibizumab
Other Names:
  • Lucentis
Experimental: Treatment Group
Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment
Drug: ranibizumab
Other Names:
  • Lucentis
Procedure: micropulse diode laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in best corrected visual acuity (BCVA)
Time Frame: baseline, 12 month
baseline, 12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
change in central macular thickness
Time Frame: baseline, 12 month
baseline, 12 month
number of intravitreal Lucentis injections
Time Frame: within 12 month
within 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GWT-TUD GmbH

Collaborators

Novartis

Investigators

  • Study Chair: Klio Ai Becker, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2014

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReCaLL-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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