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Completed

NCT Number: NCT01476449

Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retina Vitreous Associates of Florida, Clearwater, Florida, United States

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About this study

This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • Patient related considerations
  • Phakic or pseudophakic patients with a known history of diabetes will be eligible.
  • Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug.
  • Disease related considerations:
  • Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication.
  • Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40
  • Central foveal thickness on SD-OCT of >300um

Exclusion criteria

  • Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
  • Foveal ischemia on IVFA
  • Intraocular surgery less than 6 months ago
  • Epiretinal membrane of clinical significance
  • Prior vitrectomy
  • Uncontrolled glaucoma
  • Macular or peripheral laser within 90 Days from Day 0 injection
  • Intravitreal steroid injection within 90 days from Day 0 injection
  • Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection

Treatment and study plan

ranibizumab

Drug

Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.

Other names: Lucentis

Primary outcomes

  1. Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.

    Time frame: Baseline through 24 months

    The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.

Secondary outcomes

  1. Mean Number of Injections.

    Time frame: 24 months

    The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.

  2. Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).

    Time frame: 24 months

    Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.

  3. Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.

    Time frame: 24 months

    The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet.

  4. Percentage of Patients Anatomically "Dry."

    Time frame: 24 Months

    Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with "dry" maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded.

Sponsors and collaborators

Lead sponsor

Retina Vitreous Associates of Florida

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 22, 2011
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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