The Effect of Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema

The Comparison Between the Therapeutic Effect of Intravitreal Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02645734

Enrollment

133

Registered

2016-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2016-01-05

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

Conditions

Diabetic Macular Edema

Brief summary

In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema) to receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) . The study drugs were administered as often as every 4 weeks for 3 months.monitoring of best-corrected visual acuity, CST ( Central Subfield Thickness) by OCT (Optical coherence tomography) was done from base line ,4 weeks, 8weeks after injection.

Interventions

DRUGbevacizumab

1.25 mg of bevacizumab is injected

DRUGziv-aflibercept 1.25 mg

1.25 mg of ziv-aflibercept is injected

DRUGziv-aflibercept 2.5mg

2.5 mg of ziv-aflibercept is injected

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* The patient at least 18 years old had type 1 or 2 diabetes who presented with Central DME involvement (defined as retinal thickening involving 1mm central sub field thickness(CCT) * Have at least a BCVA ( best corrected visual acuity) between 20/50 to 20/320 Snellen equivalent * Have received to anti-VEGF( anti -vascular endothelial growth factor) and laser treatment within the previous 3 months

Exclusion criteria

* Uncontrolled glaucoma/uncontrolled diabet , high risk PRP(pan-retinal photocoagulation), one eye * Prior treatment with intravitreal or peribulbar injection and laser therapy during the last 3 months * Substantial cataract, history of uveitis * Macular edema due to a cause other than DME * VMT(Vitreomacular traction ) and ERM (epiretinal membrane)

Design outcomes

Primary

Measure	Time frame
visual acuity	until 6 month

Secondary

Measure	Time frame
central subfield thickness(CCT)	until 6 month

Countries

Iran

Contacts

Primary ContactMasoud Soheilian, MD

labbafi@hotmail.com009822591616

Outcome results

None listed

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