To Compare Anti-VEGF Monotherapy With Anti-VEGF and EPM Grid Laser Combination Therapy for Diabetic Macular Edema

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02462304

Acronym

END-DME

Enrollment

Registered

2015-06-04

Start date

2015-06-30

Completion date

2017-12-31

Last updated

2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macula Edema

Keywords

Diabetic Macula Edema, End-Point-Management, ranibizumab, bevacizumab

Brief summary

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.

Interventions

PROCEDUREEnd-Point-Management grid laser

DRUGranibizumab

DRUGBevacizumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years with CSME * Diagnosis of diabetes mellitus (type 1 or type 2) * At least one eye meets the study eye criteria * Able and willing to provide informed consent prior to any study-related procedures * Central foveal thickness ≥ 300 microns at baseline (SPECTRALIS or Cirrus HD OCT) * LogMAR Best corrected visual acuity 0.20 (Snellen 20/30) to 1.3 (Snellen 20/400). * Willing and able to comply with clinic visits and study-related procedures * Central Foveal Thickness on OCT 300-600 micron * After first injection, wait for ME to reduce before proceeding with the laser. Exclude if ME persists \>500um at the 4-week follow up

Exclusion criteria

* Macular edema is considered to be due to a cause other than diabetic macular edema. * An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, VMT, pigment epithelium abnormalities, dense subfoveal hard exudates, non-retinal condition such as glaucoma etc). * Substantial cataract that, in the opinion of the investigator, is likely to be affecting visual acuity. Likely to be affecting BCVA and performing laser treatment. * History of treatment for diabetic macular edema at any time in the past (such as grid macular photocoagulation). * History of treatment for diabetic macular edema at any time in the past 3 months (such as intravitreal or peribulbar corticosteroids, ranibizumab, bevacizumab, aflibercept). * Focal laser photocoagulation should be performed before enrolling into the study if needed. 3 months gap required between last laser procedure and recruitment. * History of panretinal (scatter) photocoagulation (PRP) within 3 months prior to enrollment. * Anticipated need for PRP in the study period. * History of major retinal surgery (including vitrectomy, scleral buckle, any glaucoma surgery, etc.). * History of YAG capsulotomy performed within 3 months. * Aphakia. * Intraocular pressure ≥ 25 mmHg. * History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: history of angle-closure glaucoma is not an exclusion criterion). * Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant Blepharitis. * Systemic

Design outcomes

Primary

Measure	Time frame	Description
Difference in number of anti-VEGF required	6 months	The number of injections of anti-VEGF required at the end of the 6 months period.

Secondary

Measure	Time frame	Description
Change in best corrected visual acuity	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	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	6 months	This will look at treatment related complications in terms of changes in intraocular pressure post-injection
Recurrence of macular edema	6 months	Recurrence of macular edema during the 6 months period will be monitored.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026