Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab

Sponsor

Southeast Clinical Research Associates, LLC (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03059277

Collaborator

Regeneron Pharmaceuticals (Industry)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Intravitreal Aflibercept	Phase 4

Detailed Description

This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial to determine the efficacy of intravitreal aflibercept (IAI) administered in a treat and extend fashion in eyes that have persistent centered involved diabetic macular edema despite at least 4 intravitreal injections of ranibizumab 0.3mg over 24 weeks prior to enrollment. Patients will receive intravitreal injections of aflibercept (2mg/0.05cc) at baseline and monthly until an eye has reached stability defined as: < 10% change in the Spectral Domain Optical Coherence Tomography (SD OCT) central retinal thickness (CRT) reading from the previous 2 visits (can include baseline) and less than a 5 letter decrease in Best Corrected Visual Acuity (BCVA) from best BCVA from prior visits. Once an eye has reached stability criteria, a treat and extend protocol will be used and treatment will be rendered on every visit. The duration between treatments will be extended by 2 weeks from the last visit if SD OCT extension criteria are met: < 10% change in CRT over 2 consecutive visits and < 5 letter decrease in BCVA from baseline

If at any return visit subretinal and/or intraretinal fluid recurs that causes the CRT to increase by > 10 % from its lowest level in the previous 2 consecutive visits, or CRT increases by < 10% due to subretinal and/or intraretinal fluid but is associated with a decrease of BCVA of > 5 letters from baseline then the eye will receive IAI and the treatment interval will be decreased by 1 week. If the eye has not improved or worsened for at least 2 consecutive visits and the SD OCT central subfield thickness is ≥ 300 microns or visual acuity is worse than 20/20, the following will be done:

Prior to the 24-week visit, an injection will be given. At and after the 24-week visit, an injection will be given and modified grid laser can be given at the discretion of the investigator within 7 days of IAI based on rescue criteria

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Intravitreal Aflibercept Injection (IAI) Administered in a Treat and Extend Fashion in Patients With Center Involved Diabetic Macular Edema (DME) Previously Managed With 0.3 mg Intravitreal Ranibizumab

Anticipated Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravitreal Aflibercept Intravitreal Aflibercept Injection (IAI)	Drug: Intravitreal Aflibercept Intravitreal Aflibercept 2mg

Arm

Intervention/Treatment

Experimental: Intravitreal Aflibercept

Intravitreal Aflibercept Injection (IAI)

Drug: Intravitreal Aflibercept

Intravitreal Aflibercept 2mg

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Change in Visual Acuity [52 weeks]
Mean change in Best Corrected Visual Acuity
Change in Central Subfield Thickness (CST) [52 weeks]
Mean change in CST on SD OCT compared to baseline
Number of Intravitreal Injections [52 Weeks]
Mean number of injections from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charlotte Eye Ear Nose and Throat Associates, PA	Charlotte	North Carolina	United States	28210
2	Charlotte Eye Ear Nose and Throat Associates, PA	Statesville	North Carolina	United States	28677