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

NCT03590444 | Completed Phase 4

• 1 other identifier: EK 10-147-0910
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinal Edema

Outcome Measures

Primary Outcomes (1)

• Visual acuity

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

  1 year

Secondary Outcomes (2)

• Additional morphological characteristics in spectral Domain SD-OCT

  1 year

• Central retinal thickness

  1 year

Study Arms (2)

Prompt laser group

ACTIVE COMPARATOR

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

Deferred laser group

ACTIVE COMPARATOR

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

Interventions

Ranibizumab 0.5 MG/0.05 ML Intraocular Solution DRUG

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

Also known as: Focal grid laser

Deferred laser group; Prompt laser group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Hietzing: lead

Study Sites (1)

Hietzing Hospital

Vienna, 1130, Austria

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Christopher Schütze, Ass.Prof. MD

  Hietzing Hospital Vienna, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.MD, PhD

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 18, 2018
• Study Start: April 2, 2017
• Primary Completion: April 2, 2018
• Study Completion: June 2, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

AU (1)