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

NCT02645734 | Unknown Phase 2 DMC

• 1 other identifier: 93210
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• visual acuity

  until 6 month

Secondary Outcomes (1)

• central subfield thickness(CCT)

  until 6 month

Study Arms (3)

Injection intravitreous bevacizumab

ACTIVE COMPARATOR

Injection intravitreous bevacizumab at a dose 1.25mg

Drug: bevacizumab

Injection ziv-aflibercept at dose of 1.25 mg

ACTIVE COMPARATOR

Injection ziv-aflibercept at dose of 1.25 mg

Drug: ziv-aflibercept 1.25 mg

Injection ziv-aflibercept at dose of 2.5 mg

ACTIVE COMPARATOR

Injection ziv-aflibercept at dose of 2.5 mg

Drug: ziv-aflibercept 2.5mg

Interventions

bevacizumab DRUG

1.25 mg of bevacizumab is injected

Injection intravitreous bevacizumab

ziv-aflibercept 1.25 mg DRUG

1.25 mg of ziv-aflibercept is injected

Injection ziv-aflibercept at dose of 1.25 mg

ziv-aflibercept 2.5mg DRUG

2.5 mg of ziv-aflibercept is injected

Injection ziv-aflibercept at dose of 2.5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Islamic Republic of Iran

Tehran, Iran

RECRUITING

MeSH Terms

Interventions

Bevacizumab; aflibercept

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Masoud Soheilian, MD

CONTACT

009822591616; labbafi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: January 2, 2016
• First Posted: January 5, 2016
• Primary Completion: February 1, 2016
• Last Updated: January 5, 2016

Record last verified: 2015-10

Locations

IR (1)