search
Back to results

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

Primary Purpose

Diabetic Macular Edema

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
ranibizumab
micropulse diode laser
Sponsored by
GWT-TUD GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control Group

Treatment Group

Arm Description

Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC

Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment

Outcomes

Primary Outcome Measures

change in best corrected visual acuity (BCVA)

Secondary Outcome Measures

change in central macular thickness
number of intravitreal Lucentis injections

Full Information

First Posted
February 10, 2014
Last Updated
February 21, 2017
Sponsor
GWT-TUD GmbH
Collaborators
Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT02059772
Brief Title
Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema
Acronym
ReCaLL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2014 (Actual)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GWT-TUD GmbH
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Type
Procedure
Intervention Name(s)
micropulse diode laser
Primary Outcome Measure Information:
Title
change in best corrected visual acuity (BCVA)
Time Frame
baseline, 12 month
Secondary Outcome Measure Information:
Title
change in central macular thickness
Time Frame
baseline, 12 month
Title
number of intravitreal Lucentis injections
Time Frame
within 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klio Ai Becker, MD
Official's Role
Study Chair
Facility Information:
Facility Name
Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32727496
Citation
Furashova O, Strassburger P, Becker KA, Engelmann K. Efficacy of combining intravitreal injections of ranibizumab with micropulse diode laser versus intravitreal injections of ranibizumab alone in diabetic macular edema (ReCaLL): a single center, randomised, controlled, non-inferiority clinical trial. BMC Ophthalmol. 2020 Jul 29;20(1):308. doi: 10.1186/s12886-020-01576-w.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs