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Bevacizumab and Peripheral Retinal Changes on Wide Field Angiography in Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT02096874
Recruitment Status : Unknown
Verified March 2014 by Saba al Rashaed, King Khaled Eye Specialist Hospital.
Recruitment status was:  Recruiting
First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
Saba al Rashaed, King Khaled Eye Specialist Hospital

Brief Summary:
Ultra-wide field fluorescein angiography can detect the response of anti VGEF therapy such as Avastin on retinal ischemia in the setting of diabetic macular edema.

Condition or disease Intervention/treatment Phase
Non-proliferative Diabetic Retinopathy Proliferative Diabetic Retinopathy Diabetic Macular Edema Drug: Bevacizumab Phase 4

Detailed Description:
The major causes of vision loss in diabetic retinopathy are diabetic macular edema (DME) characterized by thickening of the macula due to abnormal leakage of the retinal vasculature. Ischaemic changes and microvascular pathologies have long been hypothesized to play a role in the development of DME. In diabetic retinopathy, ischaemia stimulates the production of vascular endothelial growth factor (VEGF), which can lead to the breakdown of blood-retinal barriers, and may cause DME through an increase in retinal vessel permeability. DME is best evaluated by optical coherence tomography (OCT) while retinal ischemia is determined by Fluorescein angiography. With the avaiability of ultra wide field fluorescein angiography, the investigators can now accurately measure the degree of ischemia in peripheral retina. Thus, this study will provide us data on the degree of retinal ischemia in nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) cases as well as the measurable change that occurs in retinal ischemia after intra vitreal injection of bevacizumab.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Bevacizumab on Peripheral Retinal Changes as Imaged by Wide -Field Fluorescein Angiography in Diabetic Macular Edema
Study Start Date : June 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Bevacizumab
Each study subject will recieve Intravitreal injection of 1.25mg/0.05 cc each 5 weeks for the first 3 months then PRN for six month.
Drug: Bevacizumab
Intravitreal injection of 1.25mg/0.05 cc each 5 weeks for the first 3 months then PRN for six month
Other Name: Avastin




Primary Outcome Measures :
  1. Peripheral retinal ischemia [ Time Frame: 24 weeks ]
    Change in peripheral retinal ischemia after intravitreal bevacizumab injection in non proliferative diabetic retinopathy and proliferative diabetic retinopathy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diabetic patients at age >18year with DME
  2. Scheduled for Avastin therapy
  3. Adequate media to obtain OCT and UWFA

Exclusion Criteria:

  1. Macular pathology of any etiology
  2. Preexisting systemic disease causing retinal ischemia
  3. Previous laser or anti-VEGF treatment in past 3 months
  4. Previous retina surgery in past 2 months
  5. Allergy to fluorescein dye
  6. Psychiatric disorder, Alzheimer disease and Dementia or any other disorder precluding follow-up or continuation of the study.

Information from the National Library of Medicine

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): NCT02096874


Contacts
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Contact: Ovais M Shaikh, MD (966) 4821234 ext 1139 mshaikh@kkesh.med.sa
Contact: Abdul Rahman Hommadi (966)4821234 ext 3737 ahommadi@kkesh.med.sa

Locations
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Saudi Arabia
King Khaled Eye Specialist Hospital Recruiting
Riyadh, Saudi Arabia, 11462
Sponsors and Collaborators
King Khaled Eye Specialist Hospital
Investigators
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Principal Investigator: Saba al Rashaed, MD King Khaled Eye Specialist Hospital

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Responsible Party: Saba al Rashaed, MD, King Khaled Eye Specialist Hospital
ClinicalTrials.gov Identifier: NCT02096874    
Other Study ID Numbers: RP 1310
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Keywords provided by Saba al Rashaed, King Khaled Eye Specialist Hospital:
Peripheral retinal ischemia
ultra wide field fluorescein angiography
Bevacizumab
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors