IAI for Persistent DME After Treatment With Bevacizumab And Ranibizumab

NCT03340610 | Completed Phase 4 Results FDA Drug

• 1 other identifier: VGFTe-DME-1519
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly Intravitreal Aflibercept (IAI) doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Reduction in Macular Edema

  Reduction in macular edema measured as * Proportion of eyes with baseline SD OCT CST \>350 um demonstrating \>15% reduction at week 52 from baseline * Proportion of eyes that demonstrate SD OCT CST \<305um (males) and \<290 um (females) at week 52 from baseline

  52 weeks from baseline

Study Arms (1)

Open Label Single Arm Trial

OTHER

Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab

Drug: Alflibercept

Interventions

Alflibercept DRUG

Intravitreal Injection

Also known as: Eylea

Open Label Single Arm Trial

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adults with Diabetes Mellitus 2. Documented history of ROTATE study completion (within 3 months +/- 1 week of exit visit) 3. BCVA ETDRS visual acuity letter score 20/25-20/400 4. Thickening due to DME involving the center of the macula evident on clinical exam 5. DME on OCT at baseline (\>305 microns if male or \>290 microns if female) as assessed on Heidelberg Spectralis SD OCT 6. At least 30 days but less than 45 days since prior 0.3 mg ranibizumab injection 7. Willing and able to comply with clinic visits and study-related procedures 8. Provide signed HIPAA statement and informed consent prior to any study procedures

You may not qualify if:

• A patient who meets any of the following criteria will be excluded from the study:
• Macular edema considered to be due to a cause other than DME (ERM, Vein Occlusion, Postop CME, uveitis)
• History of PRP within 3 months prior to enrollment or anticipated need for PRP
• 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
• Clinically significant pre-retinal fibrosis involving the macula in the study eye per investigator judgment
• Intraocular inflammation of trace or above in the study eye
• Evidence of active infection in either eye
• Uncontrolled glaucoma in the study eye defined as a pressure of \> 25 on maximal medical therapy.
• Concurrent disease in the study eye, other than DME, that could compromise VA, require medical or surgical intervention during the study or could confound interpretation of the results
• Ocular media of insufficient quality to obtain fundus and OCT images
• Current treatment for a serious systemic infection
• Administration of systemic anti-angiogenic agents within 180 days of screen

Sponsors & Collaborators

• Southeast Retina Center, Georgia: lead

Study Sites (1)

Southeast Retina Center

Augusta, Georgia, 30809, United States

Location

MeSH Terms

Interventions

aflibercept

Limitations and Caveats

Small sample size, no control group with continuation of bevacizumab/ranibizumab, 6 mth time point potentially skewed as last IAI at 4 mth due to protocol amendment. Loss of OCT, Fundus, Fluorescein Angiography on 1st 5 pts due to technical error

Results Point of Contact

• Title: Dr. Dennis Marcus
• Organization: Southeast Retina Center

dmarcus@southeastretina.com

706650061

Study Officials

• Dennis M Marcus, MD

  Southeast Retina Center, PC.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: November 8, 2017
• First Posted: November 13, 2017
• Study Start: June 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 12, 2018
• Last Updated: May 24, 2019
• Results First Posted: May 1, 2019

Record last verified: 2019-05

Locations

US (1)