A Phase 2 interventional study of Aflibercept injected Pre- and Post-operatively and Aflibercept injected intraoperatively in Diabetic Macular Edema and Cataract, sponsored by Emory University. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-24.
Sponsored by Emory University · Phase 2, Interventional, and Treatment
Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
Along with age, diabetes is a major risk factor for cataract formation, which can lead to significant vision loss and disability without medical intervention. Unfortunately, diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. Reasons for this is multifactorial but includes an increased risk in the development of post-operative cystoid macular edema, and exacerbation of baseline DME. This poses a significant challenge in managing concomitant DME and visually-significant cataracts.
Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
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Exclusion Criteria:
Pre- and Post-operative time of Aflibercept injections
Drug: Aflibercept injected Pre- and Post-operatively
Intraoperative time of Aflibercept injection
Drug: Aflibercept injected intraoperatively
Three injections of aflibercept before cataract surgery, and aflibercept injections after surgery within 14-21 days of the day of surgery (number of injections depends on clinical exam findings, visual acuity and retinal thickness).
Also known as: EYELEA
Three injections of aflibercept before surgery and one injection of aflibercept during the course of the surgery by cataract surgeon.
Also known as: EYELEA
Change in best-corrected visual acuity (BCVA)
BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20.
Time frame: 1 month, 3 months and 6 months after cataract surgery
Change in optical coherence tomography (OCT) central subfield (CSF) thickness
Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded.
Time frame: 24 hours post-operatively, 1 month, 3 months and 6 months after cataract surgery
Total number of postoperative injections
Total number of postoperative injections will be calculated
Time frame: 6 months after cataract surgery
Plan to share: No — No individual de-identified participant data (including data dictionaries) will be shared. Only composite results with publication will be shared.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Emory University