## Protocol Section
### Identification Module
**NCT ID:** NCT03832179

**Acronym:** STAMP

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

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

#### Organization Study ID Info
**ID:** STAMP
#### Organization
**Class:** OTHER
**Full Name:** Bay Area Retina Associates
### Status Module
#### Completion Date
**Date:** 2022-10-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2022-03-02

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-01

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-11-15

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2019-02-06
**Type:** ACTUAL
**Study First Submit Date:** 2019-02-05
**Study First Submit QC Date:** 2019-02-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Allergan

#### Lead Sponsor

**Class:** OTHER

**Name:** Bay Area Retina Associates

#### Responsible Party

**Investigator Affiliation:** Bay Area Retina Associates

**Investigator Full Name:** Caesar Luo, MD, FACS

**Investigator Title:** Physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Diabetic Macular Edema

- Cataract

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 32

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intravitreal Bevacizumab, Ranibizumab, or Aflibercept

**Intervention Names:**

- Drug: Bevacizumab

- Drug: Ranibizumab

- Drug: Aflibercept

**Label:** Anti-vascular endothelial growth factor

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Intravitreal Ozurdex

**Intervention Names:**

- Drug: Ozurdex

**Label:** Ozurdex

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Anti-vascular endothelial growth factor

**Description:** Bevacizumab

**Name:** Bevacizumab

**Other Names:**

- Avastin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Anti-vascular endothelial growth factor

**Description:** Ranibizumab

**Name:** Ranibizumab

**Other Names:**

- Lucentis

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Anti-vascular endothelial growth factor

**Description:** Aflibercept

**Name:** Aflibercept

**Other Names:**

- Eylea

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Ozurdex

**Description:** Ozurdex

**Name:** Ozurdex

**Other Names:**

- Dexamethasone implant

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

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

**Time Frame:** 3 months after cataract surgery

#### Secondary Outcomes

**Description:** 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

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

**Time Frame:** 3 months after cataract surgery

### Eligibility Module

**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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cluo@bayarearetina.com

**Name:** Caesar Luo, MD

**Phone:** 9259436800

**Role:** CONTACT

**Contact 2:**

**Email:** fahmed@bayarearetina.com

**Name:** Farhan Ahmed

**Phone:** 9259436800

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Walnut Creek

**Contacts:**

***Contact 1:***

- **Email:** fahmed@bayarearetina.com

- **Name:** Farhan Ahmed

- **Phone:** 925-943-6800

- **Role:** CONTACT

***Contact 2:***

- **Email:** cluo@bayarearetina.com

- **Name:** Caesar Luo, MD

- **Phone:** 9259436800

- **Role:** CONTACT

***Contact 3:***

- **Name:** Roger Goldberg, MD, MBA

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Tushar Ranchod, MD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Subhransu Ray, MD, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Daniel Ting, MD, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Stewart Daniels, MD

- **Role:** SUB_INVESTIGATOR

***Contact 8:***

- **Name:** Craig Leong, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Bay Area Retina Associates

**State:** California

**Status:** RECRUITING

**Zip:** 94598

#### Overall Officials

**Official 1:**

**Affiliation:** Physician

**Name:** Caesar Luo, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 22495327

**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.

**PMID:** 28884024

**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.

**PMID:** 28196056

**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.

**PMID:** 27493795

**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.

**PMID:** 26871700

**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.

**PMID:** 17558326

**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.

**PMID:** 17962820

**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.

**PMID:** 19837384

**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.

**PMID:** 1390524

**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.

**PMID:** 25811020

**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.

**PMID:** 16540489

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007905

- Term: Lens Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000008268

- Term: Macular Degeneration

- ID: D000012162

- Term: Retinal Degeneration

- ID: D000012164

- Term: Retinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5638

- Name: Cataract

- Relevance: HIGH

- As Found: Cataract

- ID: M11261

- Name: Macular Edema

- Relevance: HIGH

- As Found: Macular Edema

- ID: M7657

- Name: Edema

- Relevance: HIGH

- As Found: Edema

- ID: M10917

- Name: Lens Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11260

- Name: Macular Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14997

- Name: Retinal Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002386

- Term: Cataract

- ID: D000008269

- Term: Macular Edema

- ID: D000004487

- Term: Edema

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000020533

- Term: Angiogenesis Inhibitors

- ID: D000043924

- Term: Angiogenesis Modulating Agents

- ID: D000006133

- Term: Growth Substances

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000006131

- Term: Growth Inhibitors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: HIGH

- As Found: Children

- ID: M257727

- Name: Aflibercept

- Relevance: HIGH

- As Found: Magnetic Resonance Imaging

- ID: M246

- Name: Bevacizumab

- Relevance: HIGH

- As Found: Non-

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M199152

- Name: BB 1101

- Relevance: LOW

- As Found: Unknown

- ID: M18681

- Name: Endothelial Growth Factors

- Relevance: LOW

- As Found: Unknown

- ID: M11900

- Name: Mitogens

- Relevance: LOW

- As Found: Unknown

- ID: M472

- Name: Ranibizumab

- Relevance: HIGH

- As Found: Dysfunction

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M22318

- Name: Angiogenesis Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9231

- Name: Growth Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003907

- Term: Dexamethasone

- ID: D000068258

- Term: Bevacizumab

- ID: D000069579

- Term: Ranibizumab

- ID: C000533178

- Term: Aflibercept

### Misc Info Module

- Version Holder: 2024-05-24
