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

Diabetic Retinal Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590444
• Other study ID #: EK 10-147-0910
• Status: Completed
• Phase: Phase 4
• Start date: April 2, 2017
• Est. completion date: June 2, 2018

Study information

• Verified date: July 2018
• Source: Hospital Hietzing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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]

Related Conditions & MeSH terms

• Diabetic Retinal Edema
• Edema
• Macular Edema
• Papilledema

Intervention

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

Locations

Country	Name	City	State
Austria	Hietzing Hospital	VIenna

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Hietzing

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Functional alterations will be followed during treatment phase, essential for verification of treatment success. Units: Snellen equivalents	1 year
Secondary	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).	1 year
Secondary	Central retinal thickness	Morphological alterations will be followed during treatment phase, essential for verification of treatment success. Units: Micrometer (retinal thickness)	1 year