Trials / Completed
CompletedNCT03590444
Treatment of Diabetic Macular Edema (DME) With Anti-VEGF and Focal Laser
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Hospital Hietzing · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-04-02
- Primary completion
- 2018-04-02
- Completion
- 2018-06-02
- First posted
- 2018-07-18
- Last updated
- 2018-07-18
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT03590444. Inclusion in this directory is not an endorsement.