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Evaluation of the Effect of Intravitreal Injections of Anti-VEGF on Macular Perfusion in Diabetic Patients Using OCTA (IMPACT)

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ClinicalTrials.gov Identifier: NCT03246152
Recruitment Status : Completed
First Posted : August 11, 2017
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ayman Gehad Elnahry, Cairo University

Tracking Information
First Submitted Date  ICMJE August 6, 2017
First Posted Date  ICMJE August 11, 2017
Last Update Posted Date December 27, 2018
Actual Study Start Date  ICMJE October 23, 2017
Actual Primary Completion Date December 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2018)
  • FAZ Area change [ Time Frame: 3-6 months ]
    Effect of repeated intravitreal Anti-VEGF injections on Foveal Avascular Zone (FAZ) area measured using the freehand tool of ImageJ
  • Macular Capillary Density change [ Time Frame: 3-6 months ]
    Effect of repeated intravitreal Anti-VEGF injections on macular capillary density using the change in the skeletonized vascular density and fractal dimension measured by ImageJ
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
  • FAZ Area change [ Time Frame: 3-6 months ]
    Effect of repeated intravitreal Anti-VEGF injections on Foveal Avascular Zone (FAZ) area using the capillary non perfusion parameter of the OCTA machine software
  • Macular Capillary Density change [ Time Frame: 3-6 months ]
    Effect of repeated intravitreal Anti-VEGF injections on macular capillary density using the change in Grid-based Vessel Density parameter in the OCTA machine software
Change History Complete list of historical versions of study NCT03246152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
  • Microaneurysms and Vascular changes [ Time Frame: 3-6 months ]
    Effect of intravitreal Anti-VEGF injections on microaneurysms and vascular changes in the superficial and deep capillary plexuses of the macula using OCTA machine software
  • BCVA change [ Time Frame: 3-6 months ]
    Correlation of BCVA change with degree of capillary non-perfusion before and after injections
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effect of Intravitreal Injections of Anti-VEGF on Macular Perfusion in Diabetic Patients Using OCTA
Official Title  ICMJE Evaluation of the Effect of Repeated Intravitreal Injections of Anti-VEGF on Macular Perfusion in Diabetic Patients Using Optical Coherence Tomography Angiography
Brief Summary

Anti-vascular endothelial growth factor (VEGF) drugs are the mainstay of therapy for diabetic macular edema (DME), substantially improving visual acuity for many diabetics worldwide, and proving effective for treatment of both non-proliferative and proliferative diabetic retinopathy.

Many studies such as Diabetic Retinopathy Clinical Research Network studies, RESTORE Study, and The BOLT Study have supported the use of different anti-VEGF agents in the treatment of DME with better visual outcomes using anti-VEGF injections alone or in combination with other treatments.

Several ocular complications of intravitreal anti-VEGF injections have been reported including endophthalmitis, cataract and retinal detachment. The effect of anti-VEGF drugs on macular perfusion has been inconclusive, with mixed reports of increase, decrease or no effect on perfusion in response to anti-VEGF treatment. In many of these studies, however, patients with more ischaemic retinas were not included. Retinal ischemia is an important factor in the progression and prognosis of diabetic retinopathy.

Fluorescein angiography (FA) was the method used to assess changes in macular perfusion after anti-VEGF injections in most of the studies. Despite its clinical usefulness, however, FA is known to have documented risks. Optical coherence tomography angiography (OCTA) is a new noninvasive method of acquiring high-resolution images of the retinal vasculature that can be utilized in the treatment of retinal disease without the need for dye injection. It allows the visualization of the superficial and deep retinal capillary layers separately and the construction of microvascular flow maps.

Several studies have proved the reliability of OCTA in detecting and quantifying macular ischemia in diabetics.

In this study, investigators aim to evaluate the effect of repeated intravitreal injections of different Anti-VEGF agents on the perfusion of different capillary layers in the macula of diabetic patients using OCTA.

Detailed Description

This is a prospective interventional study to evaluate the effect of repeated intravitreal injections of Anti-VEGF on macular perfusion in diabetic patients using optical coherence tomography angiography (OCTA).

Each patient will receive a detailed ophthalmologic examination including measurement of BCVA as well as applanation tonometry, undilated and dilated slit-lamp biomicroscopic examination and indirect fundus examination.

Duration of diabetes and its control through HbA1C measurement will be recorded for each patient.

Type 1 and 2 diabetic patients found to have BCVA worse than 6/6 and clinical evidence of macular edema will undergo SD OCT and FA.

Patients with center involved macula edema detected by SD OCT will be included in the study and will undergo baseline macular OCTA.

These patients will then undergo intravitreal injections of Anti-VEGF monthly for 3 months then OCTA will be repeated to evaluate changes in macular perfusion and SD OCT will be repeated to assess retinal thickness. Patients with center involving macular edema on SD-OCT after the first 3 injections will continue to receive intravitreal Anti-VEGF injections monthly until the edema subsides or the study duration ends. These patients then undergo a final macular OCTA for perfusion evaluation and SD OCT for thickness assessment.

OCTA will be performed with an Avanti RTVue XR system (Optovue, Inc., Fremont, CA, USA). Area of FAZ and capillary density at each capillary layer will be calculated before and after interventions using the OCTA machine software and ImageJ software.

All statistical analyses will be done using IBM SPSS v20.0 statistical software (IBM Corporation, NY, USA). Descriptive statistics will be calculated, and the data will be summarized as mean ± SD for numerical data, and as frequencies and percentages for categorical data.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Macular Edema
  • Ischemic Maculopathy
Intervention  ICMJE Drug: Bevacizumab
Repeated intravitreal injections of Bevacizumab monthly
Other Name: Avastin
Study Arms  ICMJE Experimental: Bevacizumab group
Monthly intravitreal injection of 2.5 mg of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema.
Intervention: Drug: Bevacizumab
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 24, 2018)
28
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2017)
25
Actual Study Completion Date  ICMJE December 24, 2018
Actual Primary Completion Date December 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients ≥ 18 years old
  2. Type 1 or 2 diabetes mellitus
  3. Decreased BCVA due to diabetic macular edema
  4. Center involvement by the edema on spectral domain optical coherence tomography (SD OCT)
  5. Any stage of diabetic retinopathy

Exclusion Criteria:

  1. Ocular conditions that may affect macular perfusion (e.g. retinal vascular diseases, uveitis, vasculitis etc.)
  2. History of vitreoretinal surgeries (excluding intravitreal injections)
  3. Any previous treatment for diabetic macular edema
  4. Presence of epiretinal membrane involving the macula or vitreomacular traction
  5. Media opacity preventing good image quality
  6. Uncontrolled glaucoma
  7. Thromboembolic events within 6 months
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 Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03246152
Other Study ID Numbers  ICMJE N-79-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ayman Gehad Elnahry, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Khaled E El Rakhawy, PhD Cairo University
Study Director: Karim A Raafat, PhD Cairo University
Study Chair: Ahmed AA Abdel Kader, PhD Cairo University
Principal Investigator: Ayman GA Elnahry, MSc Cairo University
PRS Account Cairo University
Verification Date December 2018

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