A Phase 4 interventional study of Bevacizumab in Diabetic Macular Edema and Ischemic Maculopathy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
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.
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.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 31 is below the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Bevacizumab
Repeated intravitreal injections of Bevacizumab monthly
Also known as: Avastin
FAZ Area Change
Effect of repeated intravitreal Anti-VEGF injections on Foveal Avascular Zone (FAZ) area measured using the freehand tool of ImageJ
Time frame: At baseline and after 3-6 consecutive monthly injections.
Macular Capillary Density Change at Full Retinal Thickness
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
Time frame: At baseline and after 3-6 consecutive monthly injections.
BCVA Change
Correlation of BCVA change with degree of capillary non-perfusion before and after injections
Time frame: At baseline and after 3-6 consecutive monthly injections.
This is the number of enrolled patients that completed the study.
| Milestone | Bevacizumab Group |
|---|---|
| Started | 31 |
| Completed | 28 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Protocol violation | 1 |
Effect of repeated intravitreal Anti-VEGF injections on Foveal Avascular Zone (FAZ) area measured using the freehand tool of ImageJ
| mm^2 | Bevacizumab Group |
|---|---|
| FAZ Area Change | 0.03 ± 0.1 |
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
| percentage of vascularity | Bevacizumab Group |
|---|---|
| Macular Capillary Density Change at Full Retinal Thickness | -2.5 ± 5.72 |
Correlation of BCVA change with degree of capillary non-perfusion before and after injections
| Logmar | Bevacizumab Group |
|---|---|
| BCVA Change | -0.21 ± 0.27 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab Group | 0/31 (0%) | 0/31 (0%) | 18/31 (58.1%) |
| Event | Bevacizumab Group |
|---|---|
| Subconjunctival hemorrhageEye disorders | 13/31 |
| Ocular irritationEye disorders | 5/31 |
| Age, Categorical(Participants) | Bevacizumab Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 28 |
| >=65 years | 3 |
| Age, Continuous(Years) | Bevacizumab Group |
|---|---|
| Mean | 54.8 ± 6.5 |
| Sex: Female, Male(Participants) | Bevacizumab Group |
|---|---|
| Female | 17 |
| Male | 14 |
| Race (NIH/OMB)(Participants) | Bevacizumab Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 31 |
| Region of Enrollment(participants) | Bevacizumab Group |
|---|---|
| Egypt | 31 |
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Cairo University