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Treatment of Diabetic Macular Edema (DME) With Anti-VEGF and Focal Laser

Primary Purpose

Diabetic Retinal Edema

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Ranibizumab 0.5 MG/0.05 ML Intraocular Solution
Sponsored by
Hospital Hietzing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinal Edema

Eligibility Criteria

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

Inclusion criteria:

  • DME that will be detected clinically and on FA as well as on SD-OCT [diffuse macular edema with central retinal thickness (CRT) ≥300µm involving the center of the macular area]
  • Patients will be included into the present study following informed consent
  • Best-corrected-visual-acuity (BCVA) between 0.06 (1.2logMAR) and 0.63 (0.20logMAR).

Exclusion criteria:

  • Eyes with other retinal diseases [i.e. age-related macular degeneration (AMD) and associated choroidal neovascularization (CNV), cystoid macular edema (CME) of other origin (e.g. uveitis, Irvine-Gass syndrome, retinal vein occlusion), or retinal dystrophies]

Sites / Locations

  • Hietzing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prompt laser group

Deferred laser group

Arm Description

Eyes of eligible patients will be randomized (ratio 1:1) and receive ranibizumab and focal/grid laser on the same day (prompt' group, 25 eyes, 50%). Interventions: ranibizumab and focal/grid laser on the same day [Ranibizumab (Ranibizumab 0.5 MG/0.05 ML Intraocular Solution]

Eyes of eligible patients will be randomized (ratio 1:1) and receive ranibizumab and focal/grid laser on one week prior to laser treatment (deferred' group, 25 eyes, 50%). Interventions: ranibizumab and focal/grid laser on one week prior to laser treatment [Ranibizumab 0.5 MG/0.05 ML Intraocular Solution]

Outcomes

Primary Outcome Measures

Visual acuity
Functional alterations will be followed during treatment phase, essential for verification of treatment success. Units: Snellen equivalents

Secondary Outcome Measures

Additional morphological characteristics in spectral Domain SD-OCT
Intraretinal morphological features found in SD- OCT Imaging (i.e. intraretinal morphological changes senn on SD-OCT).
Central retinal thickness
Morphological alterations will be followed during treatment phase, essential for verification of treatment success. Units: Micrometer (retinal thickness)

Full Information

First Posted
June 14, 2018
Last Updated
July 17, 2018
Sponsor
Hospital Hietzing
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1. Study Identification

Unique Protocol Identification Number
NCT03590444
Brief Title
Treatment of Diabetic Macular Edema (DME) With Anti-VEGF and Focal Laser
Official Title
Treatment of Diabetic Macular Edema (DME) With Intravitreal Anti-vascular Endothelial Growth Factor (Anti-VEGF) and Prompt Versus Deferred Focal Laser During Long-term Follow-up and Identification of Prognostic Retinal Markers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2, 2017 (Actual)
Primary Completion Date
April 2, 2018 (Actual)
Study Completion Date
June 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Hietzing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics.
Detailed Description
Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics. Prospective clinical trial (50 treatment-naive eyes) with DME randomized 1:1 receiving intravitreal ranibizumab (0.5 mg/0.05 ml) and prompt grid laser compared to ranibizumab and deferred laser. Morphological characteristics potentially relevant for prognosis were assessed at baseline, month 6, month 9, year 1, 2, 3, 4 and 5 of follow-up. Grid laser and ranibizumab therapy is expected to be effective in DME management during long-term follow-up. Immediate combined therapy will likely signify a trend of functional superiority in an early disease phase. Intraretinal hyperreflective material in SD-OCT will likely negatively related to BCVA.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Prompt laser group
Arm Type
Active Comparator
Arm Description
Eyes of eligible patients will be randomized (ratio 1:1) and receive ranibizumab and focal/grid laser on the same day (prompt' group, 25 eyes, 50%). Interventions: ranibizumab and focal/grid laser on the same day [Ranibizumab (Ranibizumab 0.5 MG/0.05 ML Intraocular Solution]
Arm Title
Deferred laser group
Arm Type
Active Comparator
Arm Description
Eyes of eligible patients will be randomized (ratio 1:1) and receive ranibizumab and focal/grid laser on one week prior to laser treatment (deferred' group, 25 eyes, 50%). Interventions: ranibizumab and focal/grid laser on one week prior to laser treatment [Ranibizumab 0.5 MG/0.05 ML Intraocular Solution]
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.5 MG/0.05 ML Intraocular Solution
Other Intervention Name(s)
Focal grid laser
Intervention Description
Focal laser treatment will be performed using argon laser photocoagulation (VISULAS 532s®, Carl Zeiss Meditec) operating at 532nm and Ranibizumab 0.5 MG/0.05 ML Intraocular Solution. Ranibizumab 0.5 MG/0.05 ML Intraocular Solution
Primary Outcome Measure Information:
Title
Visual acuity
Description
Functional alterations will be followed during treatment phase, essential for verification of treatment success. Units: Snellen equivalents
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Additional morphological characteristics in spectral Domain SD-OCT
Description
Intraretinal morphological features found in SD- OCT Imaging (i.e. intraretinal morphological changes senn on SD-OCT).
Time Frame
1 year
Title
Central retinal thickness
Description
Morphological alterations will be followed during treatment phase, essential for verification of treatment success. Units: Micrometer (retinal thickness)
Time Frame
1 year

10. Eligibility

Sex
All
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: DME that will be detected clinically and on FA as well as on SD-OCT [diffuse macular edema with central retinal thickness (CRT) ≥300µm involving the center of the macular area] Patients will be included into the present study following informed consent Best-corrected-visual-acuity (BCVA) between 0.06 (1.2logMAR) and 0.63 (0.20logMAR). Exclusion criteria: Eyes with other retinal diseases [i.e. age-related macular degeneration (AMD) and associated choroidal neovascularization (CNV), cystoid macular edema (CME) of other origin (e.g. uveitis, Irvine-Gass syndrome, retinal vein occlusion), or retinal dystrophies]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Schütze, Ass.Prof. MD
Organizational Affiliation
Hietzing Hospital Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hietzing Hospital
City
VIenna
ZIP/Postal Code
1130
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Treatment of Diabetic Macular Edema (DME) With Anti-VEGF and Focal Laser

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