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

Sponsor
Hospital Hietzing (Other)
Overall Status
Completed
CT.gov ID
NCT03590444
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
14
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 2, 2017
Actual Primary Completion Date :
Apr 2, 2018
Actual Study Completion Date :
Jun 2, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Prompt laser group

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]

Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution
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
Other Names:
  • Focal grid laser

    		•
    Active Comparator: Deferred laser group

    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]

    Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution
    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
    Other Names:
  • Focal grid laser

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [1 year]

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

    Secondary Outcome Measures

    1. Additional morphological characteristics in spectral Domain SD-OCT [1 year]

      Intraretinal morphological features found in SD- OCT Imaging (i.e. intraretinal morphological changes senn on SD-OCT).

    2. Central retinal thickness [1 year]

      Morphological alterations will be followed during treatment phase, essential for verification of treatment success. Units: Micrometer (retinal thickness)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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]

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hietzing Hospital VIenna Austria 1130

    Sponsors and Collaborators

    • Hospital Hietzing

    Investigators

    • Principal Investigator: Christopher Schütze, Ass.Prof. MD, Hietzing Hospital Vienna, Austria

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christopher Schütze, Ass.Prof., MD, PhD, Ass.Prof.MD, PhD, Hospital Hietzing
    ClinicalTrials.gov Identifier:
    NCT03590444
    Other Study ID Numbers:
    • EK 10-147-0910
    First Posted:
    Jul 18, 2018
    Last Update Posted:
    Jul 18, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Papilledema
    Macular Edema
    Edema
    Ranibizumab

    Study Results

    No Results Posted as of Jul 18, 2018