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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

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE March 26, 2014
Last Update Posted Date March 26, 2014
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab and Peripheral Retinal Changes on Wide Field Angiography in Diabetic Macular Edema
Official Title  ICMJE The Effect of Bevacizumab on Peripheral Retinal Changes as Imaged by Wide -Field Fluorescein Angiography in Diabetic Macular Edema
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-proliferative Diabetic Retinopathy
  • Proliferative Diabetic Retinopathy
  • Diabetic Macular Edema
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 25, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02096874
Other Study ID Numbers  ICMJE RP 1310
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Saba al Rashaed, King Khaled Eye Specialist Hospital
Study Sponsor  ICMJE King Khaled Eye Specialist Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Saba al Rashaed, MD King Khaled Eye Specialist Hospital
PRS Account King Khaled Eye Specialist Hospital
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP