A Phase 4 interventional study of End-Point-Management grid laser and ranibizumab in Diabetic Macula Edema, sponsored by The University of Hong Kong. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-19.
Sponsored by The University of Hong Kong · Phase 4, Interventional, and Treatment
Objectives:
To compare the efficacy of monotherapy with anti-Vascular Endothelial Growth Factor (ranibizumab or bevacizumab) with combined therapy with anti-Vascular Endothelial Growth Factor and end-point-management grid laser photocoagulation for diabetic macular edema.
Study design:
Open-label non-randomized interventional study.
Study overview:
This study aims to look at the efficacy of treating diabetic macular edema (DME) with either anti-Vascular Endothelial Growth Factor(anti-VEGF) monotherapy, compared with combination therapy with anti-VEGF and End-Point-Management (EPM) grid laser photocoagulation, over a period of 6 months.
Various sites from across Asia (Japan, South Korea, Hong Kong) will participate. Depending on the availability of EPM laser, sites can either contribute to the 'Anti-VEGF monotherapy' arm, or to the 'Combination therapy' arm.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive both anti-VEGF injections and EPM laser.
Procedure: End-Point-Management grid laser · Drug: ranibizumab · Drug: Bevacizumab
Subjects will receive anti-VEGF injections monotherapy.
Drug: ranibizumab · Drug: Bevacizumab
Difference in number of anti-VEGF required
The number of injections of anti-VEGF required at the end of the 6 months period.
Time frame: 6 months
Change in best corrected visual acuity
The change in best corrected visual acuity among subjects in different groups at the end of the 6 months period when compared to baseline.
Time frame: 6 months
Central retinal thickness
The change in central retinal thickness among subjects in different groups at the end of the 6 months period when compared to baseline.
Time frame: 6 months
Treatment related complications
This will look at treatment related complications in terms of changes in intraocular pressure post-injection
Time frame: 6 months
Treatment related complications
This will look at treatment related complications in terms of infection
Time frame: 6 months
Treatment related complications
This will look at treatment related complications in terms of retinal detachment
Time frame: 6 months
Recurrence of macular edema
Recurrence of macular edema during the 6 months period will be monitored.
Time frame: 6 months
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong