Recruiting
Phase 1
Phase 2

Ranibizumab & Bevacizumab

Sponsor:

Southeast Retina Center, Georgia

Code:

NCT01845844

Conditions

Diabetic Macular Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ranibizumab 0.3mg/0.05cc

Study Details

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

Study ID

NCT01845844

Start date

Apr, 2013

Status verified date

Sep, 2014

Completion date

Jan, 2015

Anticipated

Primary completion date

Jan, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ranibizumab 0.3mg (12 months)

Intravitreal injection of ranibizumab 0.3mg/0.05cc

active comparator: Ranibizumab 0.3mg (6 months)

Intravitreal injection of ranibizumab 0.3mg/0.05cc

Interventions

Ranibizumab 0.3mg/0.05cc

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.

Primary outcome measure

  • Incidence of ocular and systemic adverse events will be compared between experimental and active comparator groups [ Time Frame: 1 year ]
  • Severity of ocular and systemic adverse events will be compared between experimental and active comparator groups [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Dennis M Marcus, M.D.

706-650-0061dmarcus@southeastretina.com

Locations

Southeast Retina Center, PC

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Dennis M Marcus, MD

706-650-0061dmarcus@southeastretina.com

Jared Gardner, BS

706-650-0061jgardner@southeastretina.com

Principal Investigator:

Dennis M Marcus, M.D.

More Information

Sponsor

Southeast Retina Center, Georgia

Last update posted

Sep 17, 2014

Last verified

Sep, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southeast Retina Center, Georgia on 2014-09-17.