Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification
NCT ID: NCT03832179
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
16 participants
INTERVENTIONAL
2018-11-15
2024-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Anti-vascular endothelial growth factor
Intravitreal Bevacizumab, Ranibizumab, or Aflibercept
Bevacizumab
Bevacizumab
Ranibizumab
Ranibizumab
Aflibercept
Aflibercept
Ozurdex
Intravitreal Ozurdex
Ozurdex
Ozurdex
Interventions
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Bevacizumab
Bevacizumab
Ranibizumab
Ranibizumab
Aflibercept
Aflibercept
Ozurdex
Ozurdex
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gender- All
* Race- All
* Diagnosis of Diabetes (Type 1 or 2) with a concomitant diagnosis of diabetic macular edema as demonstrated on spectral domain optical coherence tomography (Heidelberg Spectralis)
* \>250 microns central foveal thickness
* Able and willing to provide informed consent
Exclusion Criteria
* A condition that in the opinion of the investigator would preclude participation
* Participation in another investigational trial within 30 days of randomization
* Application of focal macular laser within 120 days of enrollment
* Administration of Iluvien implant within 3 years of enrollment
* Administration of intravitreal triamcinolone within 3 months of enrollment
* Administration of any anti-vascular endothelial growth factor agent within 30 days of enrollment
* Known hypersensitivity to any of the investigational products
* Blood pressure \>180/110
* Women who are pregnant, lactating, or intend to become pregnant within 1 year of randomization
* Vulnerable populations- including but not limited to wards of the state, cognitively impaired individuals, prisoners, institutionalized individuals
* Individual is planning on moving within 6 months of study enrollment
* Macular edema secondary to cause other than diabetic macular edema
* Ocular condition that, in the opinion of the investigators, may affect course of macular edema during course of study (vein occlusion, uveitis, etc.)
* Evidence of ocular infections
* Evidence of uncontrolled glaucoma
* Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex
18 Years
ALL
Yes
Sponsors
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Allergan
INDUSTRY
Bay Area Retina Associates
OTHER
Responsible Party
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Caesar Luo, MD, FACS
Physician
Principal Investigators
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Caesar Luo, MD
Role: PRINCIPAL_INVESTIGATOR
Physician
Locations
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Bay Area Retina Associates
Walnut Creek, California, United States
Countries
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References
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Rauen PI, Ribeiro JA, Almeida FP, Scott IU, Messias A, Jorge R. Intravitreal injection of ranibizumab during cataract surgery in patients with diabetic macular edema. Retina. 2012 Oct;32(9):1799-803. doi: 10.1097/IAE.0b013e31824bebb8.
Furino C, Boscia F, Niro A, Giancipoli E, Grassi MO, D'amico Ricci G, Blasetti F, Reibaldi M, Alessio G. Combined Phacoemulsification and Intravitreal Dexamethasone Implant (Ozurdex(R)) in Diabetic Patients with Coexisting Cataract and Diabetic Macular Edema. J Ophthalmol. 2017;2017:4896036. doi: 10.1155/2017/4896036. Epub 2017 Aug 13.
Calvo P, Ferreras A, Al Adel F, Dangboon W, Brent MH. EFFECT OF AN INTRAVITREAL DEXAMETHASONE IMPLANT ON DIABETIC MACULAR EDEMA AFTER CATARACT SURGERY. Retina. 2018 Mar;38(3):490-496. doi: 10.1097/IAE.0000000000001552.
Yumusak E, Ornek K. Comparison of Perioperative Ranibizumab Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery. J Ophthalmol. 2016;2016:7945619. doi: 10.1155/2016/7945619. Epub 2016 Jul 14.
Lim LL, Morrison JL, Constantinou M, Rogers S, Sandhu SS, Wickremasinghe SS, Kawasaki R, Al-Qureshi S. Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery - preliminary 6 month results. Clin Exp Ophthalmol. 2016 May;44(4):233-42. doi: 10.1111/ceo.12720. Epub 2016 Mar 29.
Schmier JK, Halpern MT, Covert DW, Matthews GP. Evaluation of costs for cystoid macular edema among patients after cataract surgery. Retina. 2007 Jun;27(5):621-8. doi: 10.1097/01.iae.0000249577.92800.c0.
Hayashi K, Igarashi C, Hirata A, Hayashi H. Changes in diabetic macular oedema after phacoemulsification surgery. Eye (Lond). 2009 Feb;23(2):389-96. doi: 10.1038/sj.eye.6703022. Epub 2007 Oct 26.
Hartnett ME, Tinkham N, Paynter L, Geisen P, Rosenberg P, Koch G, Cohen KL. Aqueous vascular endothelial growth factor as a predictor of macular thickening following cataract surgery in patients with diabetes mellitus. Am J Ophthalmol. 2009 Dec;148(6):895-901.e1. doi: 10.1016/j.ajo.2009.07.014. Epub 2009 Oct 17.
Ferguson VM, Spalton DJ. Continued breakdown of the blood aqueous barrier following cataract surgery. Br J Ophthalmol. 1992 Aug;76(8):453-6. doi: 10.1136/bjo.76.8.453.
Dong N, Xu B, Wang B, Chu L, Tang X. Aqueous cytokines as predictors of macular edema in patients with diabetes following uncomplicated phacoemulsification cataract surgery. Biomed Res Int. 2015;2015:126984. doi: 10.1155/2015/126984. Epub 2015 Feb 25.
Patel JI, Hykin PG, Cree IA. Diabetic cataract removal: postoperative progression of maculopathy--growth factor and clinical analysis. Br J Ophthalmol. 2006 Jun;90(6):697-701. doi: 10.1136/bjo.2005.087403. Epub 2006 Mar 15.
Other Identifiers
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STAMP
Identifier Type: -
Identifier Source: org_study_id
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