Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab

NCT03059277 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: VGFTe-DME-1432
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the efficacy of intravitreal aflibercept injections administered in a treat and extend fashion in eyes that have persistent center involved diabetic macular edema following at least 4 intravitreal injections of 0.3 mg ranibizumab over 24 weeks.

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema; Diabetes; reduced treatment frequency

Outcome Measures

Primary Outcomes (1)

• Change in Central Subfield Thickness (CST)

  Percentage of patients who experience a \> 10% decrease in mean Central Subfield Thickness (CST) from baseline or whose CST \< 300 microns at 52 weeks.

  52 weeks

Secondary Outcomes (3)

• Mean Change in Visual Acuity

  52 weeks

• Change in Central Subfield Thickness (CST)

  52 weeks

• Number of Intravitreal Injections

  52 Weeks

Study Arms (1)

Intravitreal Aflibercept

EXPERIMENTAL

Intravitreal Aflibercept Injection (IAI)

Drug: Intravitreal Aflibercept

Interventions

Intravitreal Aflibercept DRUG

Intravitreal Aflibercept 2mg

Intravitreal Aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years with type 1 or type 2 diabetes
• Best Corrected Visual Acuity (by ETDRS) letter score in study eye ≤ 85 and ≥24 (approximate Snellen equivalent 20/20 to 20/320)
• Central retinal thickness on SD OCT at baseline visit of \> 300 microns using Heidelberg Spectralis with definite evidence of intraretinal or subretinal fluid due to diabetic retinopathy in the CSF.
• Patients must have received at least four intravitreal ranibizumab 0.3 mg injections within 24 weeks prior to screening and failed to have had complete resolution of intraretinal or subretinal fluid on SD OCT and a CRT \> 300 microns using Heidelberg Spectralis

You may not qualify if:

• Laser photocoagulation (panretinal or macular) in the study within 90 days of baseline
• Active high risk proliferative diabetic retinopathy (PDR)
• History of intravitreal corticosteroids within 4 months of baseline
• History of intravitreal bevacizumab within 24 weeks of baseline
• History of idiopathic or autoimmune uveitis in the study eye
• Cataract surgery in the study eye within 90 days of baseline
• Any intraocular surgery within 90 days of baseline
• Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect vision
• Evidence of active infection in either eye
• Uncontrolled glaucoma in the study eye defined as a pressure of \> 25 mmHg on maximal medical therapy.

Sponsors & Collaborators

• Southeast Clinical Research Associates, LLC: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (2)

Charlotte Eye Ear Nose and Throat Associates, PA

Charlotte, North Carolina, 28210, United States

Location

Charlotte Eye Ear Nose and Throat Associates, PA

Statesville, North Carolina, 28677, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Andrew N Antoszyk, MD

  Charlotte Eye Ear Nose and Throat Assciates, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 23, 2017
• Study Start: June 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: June 14, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)