To Compare Anti-VEGF Monotherapy With Anti-VEGF and EPM Grid Laser Combination Therapy for Diabetic Macular Edema (END-DME)
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|ClinicalTrials.gov Identifier: NCT02462304|
Recruitment Status : Unknown
Verified April 2016 by Dr. WONG Yat-hin Ian, The University of Hong Kong.
Recruitment status was: Enrolling by invitation
First Posted : June 4, 2015
Last Update Posted : April 19, 2016
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.
Open-label non-randomized interventional study.
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macula Edema||Procedure: End-Point-Management grid laser Drug: ranibizumab Drug: Bevacizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||To Compare the Efficacy of Monotherapy With Anti-Vascular Endothelial Growth Factor (Ranibizumab or Bevacizumab) Versus Combination Therapy With Anti-Vascular Endothelial Growth Factor and End-point-management Grid Laser Photocoagulation for Diabetic Macular Edema|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Combination Anti-VEGF and EPM laser
Subjects will receive both anti-VEGF injections and EPM laser.
Procedure: End-Point-Management grid laser
Active Comparator: Anti-VEGF monotherapy
Subjects will receive anti-VEGF injections monotherapy.
- Difference in number of anti-VEGF required [ Time Frame: 6 months ]The number of injections of anti-VEGF required at the end of the 6 months period.
- Change in best corrected visual acuity [ Time Frame: 6 months ]The change in best corrected visual acuity among subjects in different groups at the end of the 6 months period when compared to baseline.
- Central retinal thickness [ Time Frame: 6 months ]The change in central retinal thickness among subjects in different groups at the end of the 6 months period when compared to baseline.
- Treatment related complications [ Time Frame: 6 months ]This will look at treatment related complications in terms of changes in intraocular pressure post-injection
- Treatment related complications [ Time Frame: 6 months ]This will look at treatment related complications in terms of infection
- Treatment related complications [ Time Frame: 6 months ]This will look at treatment related complications in terms of retinal detachment
- Recurrence of macular edema [ Time Frame: 6 months ]Recurrence of macular edema during the 6 months period will be monitored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462304
|The University of Hong Kong|
|Hong Kong, China|
|Principal Investigator:||Ian Wong, FRCOphth||The University of Hong Kong|