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

Primary Purpose

Diabetic Macular Edema, Cataract

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bevacizumab

Ranibizumab

Aflibercept

Ozurdex

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Evidence of uncontrolled glaucoma
Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex

Sites / Locations

Bay Area Retina AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Anti-vascular endothelial growth factor

Ozurdex

Arm Description

Intravitreal Bevacizumab, Ranibizumab, or Aflibercept

Intravitreal Ozurdex

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Snellen visual acuity will be measured and converted into logMAR 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

Full Information

NCT ID

NCT03832179

First Posted

February 5, 2019

Last Updated

March 1, 2022

Sponsor

Bay Area Retina Associates

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT03832179

Brief Title

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

Acronym

STAMP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2018 (Actual)

Primary Completion Date

July 1, 2022 (Anticipated)

Study Completion Date

October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bay Area Retina Associates

Collaborators

Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

In patients with pre-existing diabetic macular edema, anti-vascular endothelial growth factor therapy (Bevacizumab, ranibizumab, or aflibercept) will be compared to Ozurdex therapy administered 1 week prior to phacoemulsification cataract extraction. Spectral domain optical coherence tomography and visual acuity will be acquired at 1 week, 1 month, 2 months, and 3 months following cataract surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema, Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anti-vascular endothelial growth factor

Arm Type

Active Comparator

Arm Description

Intravitreal Bevacizumab, Ranibizumab, or Aflibercept

Arm Title

Ozurdex

Arm Type

Experimental

Arm Description

Intravitreal Ozurdex

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Bevacizumab

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

Ranibizumab

Intervention Type

Drug

Intervention Name(s)

Aflibercept

Other Intervention Name(s)

Eylea

Intervention Description

Aflibercept

Intervention Type

Drug

Intervention Name(s)

Ozurdex

Other Intervention Name(s)

Dexamethasone implant

Intervention Description

Ozurdex

Primary Outcome Measure Information:

Title

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

Description

Time Frame

3 months after cataract surgery

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

3 months after cataract surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Evidence of uncontrolled glaucoma Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caesar Luo, MD

Phone

9259436800

cluo@bayarearetina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Farhan Ahmed

Phone

9259436800

fahmed@bayarearetina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Caesar Luo, MD

Organizational Affiliation

Physician

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bay Area Retina Associates

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Farhan Ahmed

Phone

925-943-6800

fahmed@bayarearetina.com

First Name & Middle Initial & Last Name & Degree

Caesar Luo, MD

Phone

9259436800

cluo@bayarearetina.com

First Name & Middle Initial & Last Name & Degree

Roger Goldberg, MD, MBA

First Name & Middle Initial & Last Name & Degree

Tushar Ranchod, MD

First Name & Middle Initial & Last Name & Degree

Subhransu Ray, MD, PhD

First Name & Middle Initial & Last Name & Degree

Daniel Ting, MD, PhD

First Name & Middle Initial & Last Name & Degree

Stewart Daniels, MD

First Name & Middle Initial & Last Name & Degree

Craig Leong, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22495327

Citation

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.

Results Reference

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PubMed Identifier

28884024

Citation

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.

Results Reference

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PubMed Identifier

28196056

Citation

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.

Results Reference

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PubMed Identifier

27493795

Citation

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.

Results Reference

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PubMed Identifier

26871700

Citation

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.

Results Reference

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PubMed Identifier

17558326

Citation

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.

Results Reference

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PubMed Identifier

17962820

Citation

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.

Results Reference

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PubMed Identifier

19837384

Citation

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.

Results Reference

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PubMed Identifier

1390524

Citation

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.

Results Reference

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PubMed Identifier

25811020

Citation

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.

Results Reference

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PubMed Identifier

16540489

Citation

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.

Results Reference

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

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