Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab

NCT01845844 | Unknown Phase 1

• 1 other identifier: ML28713
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, Phase I/II study of Intravitreally administered 0.3mg ranibizumab in subjects with persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at least 6 bevacizumab injections within 9 months of enrollment).

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• Incidence of ocular and systemic adverse events will be compared between experimental and active comparator groups

  Examples include worsened acuity of greater than 30 letters, retinal detachment, endophthalmitis, cataract progression, vitreous hemorrhage, new PDR or neovascularization of the iris or angle, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs and will include thromboembolic events, deaths and systemic serious adverse events

  1 year

• Severity of ocular and systemic adverse events will be compared between experimental and active comparator groups

  Examples include worsened acuity of greater than 30 letters, retinal detachment, endophthalmitis, cataract progression, vitreous hemorrhage, new PDR or neovascularization of the iris or angle, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs and will include thromboembolic events, deaths and systemic serious adverse events

  1 year

Secondary Outcomes (1)

• Efficacy of monthly and monthly followed by PRN dosing of 0.3 mg ranibizumab after persistent DME despite previous bevacizumab therapy

  1 year

Other Outcomes (2)

• Mean BCVA letter score

  Baseline, 1, 3, 6, 9, and 12 months

• Mean OCT CSF thickness and macular volume

  Baseline, 1, 3, 6, 9, and 12 months

Study Arms (2)

Ranibizumab 0.3mg (12 months)

EXPERIMENTAL

Intravitreal injection of ranibizumab 0.3mg/0.05cc

Drug: Ranibizumab 0.3mg/0.05cc

Ranibizumab 0.3mg (6 months)

ACTIVE COMPARATOR

Intravitreal injection of ranibizumab 0.3mg/0.05cc

Drug: Ranibizumab 0.3mg/0.05cc

Interventions

Ranibizumab 0.3mg/0.05cc DRUG

Group A (Arm A) will receive monthly 0.3mg/0.05cc intravitreal injections for 12 consecutive months. Group B (Arm B) will receive monthly 0.3mg/0.05cc intravitreal injections for the first six months and then PRN for the remaining 6 months per protocol specified criteria.

Also known as: Lucentis

Ranibizumab 0.3mg (12 months); Ranibizumab 0.3mg (6 months)

Eligibility Criteria

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

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• \>=18 years
• Type I/II diabetes mellitus
• Central-involved DME in study eye (OCT CSF \>=275um on Heidelberg Spectralis spectral domain OCT with evidence of intraretinal or subretinal fluid or cysts)
• Definite retinal thickening due to diabetic macular edema involving the center of the macula.
• Media clarity, pupillary dilation and individual cooperation for adequate fungus photography and fluorescein angiography.
• Visual Acuity score in study eye \<=80 and \>=20 (approximate Snellen equivalent 20/25 to 20/400).
• History of at least 6 intravitreal bevacizumab injections within the past 9 months and 2 intravitreal bevacizumab injections within the past 2 months.
• No history of an anti-VEGF treatment for DME in the past 3 weeks.
• No other DME treatment for DME, other than bevacizumab, in the study eye at any time in the past 3 months.
• No history of major ocular surgery in the study eye within prior 3 months or anticipated within the next six months following randomization.

You may not qualify if:

• Pregnancy or lactation
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another medical investigation or trial within 30 days of randomization
• Known allergy to ranibizumab
• Acute cardiovascular event requiring hospitalization within the past 3 months
• Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization or anticipated use during the study
• Macular edema is considered to be due to a cause other than DME
• An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from the resolution of macular edema
• History of intravitreal anti-vascular endothelial growth factor (anti-VEGF) agent other than bevacizumab within 9 months prior to randomization
• History of panretinal photocoagulation within 3 months prior to randomization or anticipated need for panretinal photocoagulation in the 6 months following randomization
• Yag capsulotomy performed within 1 month prior to randomization
• External ocular infection including conjunctivitis, significant blepharitis, etc.

Sponsors & Collaborators

• Southeast Retina Center, Georgia: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Southeast Retina Center, PC

Augusta, Georgia, 30909, United States

RECRUITING

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dennis M Marcus, M.D.

  Southeast Retina Center

  STUDY DIRECTOR

Central Study Contacts

Dennis M Marcus, M.D.

CONTACT

706-650-0061; dmarcus@southeastretina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Dennis M. Marcus Principal Investigator

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

US (1)