Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification

NCT03832179 | Completed Phase 4 FDA Drug

• 1 other identifier: STAMP
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the efficacy of antecedent intravitreal anti-vascular endothelial growth factor therapy vs. Ozurdex in reducing post-cataract surgery related macular edema in patients with pre-existing diabetic macular edema.

Conditions

Diabetic Macular Edema; Cataract

Outcome Measures

Primary Outcomes (1)

• Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy

  Central foveal thickness will be measured in microns by spectral domain optical coherence tomography (Heidelberg) and compared to baseline at post-operative week 1, postoperative month 1, postoperative month 2, and postoperative month 3 for both anti-vascular endothelial growth factor and Ozurdex groups

  3 months after cataract surgery

Secondary Outcomes (1)

• Visual acuity outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy

  3 months after cataract surgery

Study Arms (2)

Anti-vascular endothelial growth factor

ACTIVE COMPARATOR

Intravitreal Bevacizumab, Ranibizumab, or Aflibercept

Drug: Bevacizumab; Drug: Ranibizumab; Drug: Aflibercept

Ozurdex

EXPERIMENTAL

Intravitreal Ozurdex

Drug: Ozurdex

Interventions

Bevacizumab DRUG

Bevacizumab

Also known as: Avastin

Anti-vascular endothelial growth factor

Ranibizumab DRUG

Ranibizumab

Also known as: Lucentis

Anti-vascular endothelial growth factor

Aflibercept DRUG

Aflibercept

Also known as: Eylea

Anti-vascular endothelial growth factor

Ozurdex DRUG

Ozurdex

Also known as: Dexamethasone implant

Ozurdex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years of age
• 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

You may not qualify if:

• Significant renal disease
• 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

Sponsors & Collaborators

• Bay Area Retina Associates: lead
• Allergan: collaborator

Study Sites (1)

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Related Publications (11)

• 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.

  PMID: 22495327 BACKGROUND

• 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.

  PMID: 28884024 BACKGROUND

• 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.

  PMID: 28196056 BACKGROUND

• 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.

  PMID: 27493795 BACKGROUND

• 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.

  PMID: 26871700 BACKGROUND

• 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.

  PMID: 17558326 BACKGROUND

• 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.

  PMID: 17962820 BACKGROUND

• 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.

  PMID: 19837384 BACKGROUND

• 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.

  PMID: 1390524 BACKGROUND

• 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.

  PMID: 25811020 BACKGROUND

• 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.

  PMID: 16540489 BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Bevacizumab; Ranibizumab; aflibercept; Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Caesar Luo, MD

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Two parallel groups, one group receiving anti-vascular endothelial growth factor and the other group receiving Ozurdex.

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 6, 2019
• Study Start: November 15, 2018
• Primary Completion: September 1, 2023
• Study Completion: March 30, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)