Skip to main content
OpenTrials
Completed

NCT Number: NCT01982435

Safety and Efficacy of Ranibizumab for Diabetic Macular Edema

The primary objective of the study is to assess the ocular and systemic adverse events of ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with intravitreal bevacizumab (Avastin).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Macular Edema Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Macular Degeneration Macular Edema Metabolic Diseases Nutritional and Metabolic Diseases Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States

Loading trial locations.

About this study

This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab (Lucentis) in subjects with DME (diabetic macular edema) previously treated with intravitreal bevacizumab (Avastin) with a randomized comparative dosing strategy, monthly vs "treat-and-extend." Thirty patients total will be enrolled in the study, 15 in each group. This study will have a 1-year treatment period. The recruitment period will occur over 1 year with total potential study duration of 2 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects will be eligible if the following criteria are met:
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • ETDRS best-corrected visual acuity of 20/25 to 20/320 in the study eye
  • Willing, committed, and able to return for ALL clinic visits and complete all study related procedures
  • At least 6 previous bevacizumab injections for diabetic macular edema in the last 12 months in the study eye.
  • At least 2 bevacizumab injections within 10 weeks and the most recent bevacizumab injection within 6 weeks of baseline study visits in the study eye.
  • Persistent foveal-involving diabetic macular edema based on presence of intraretinal and/or subretinal fluid by SDOCT in the foveal center at study entry in the study eye.

Exclusion criteria

Subjects who meet any of the following criteria will be excluded from this study:

  • 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 (intrauterine device), or contraceptive hormone implant or patch.
  • Intravitreal steroid or periocular steroid treatment within 3 months of study entry in the study eye.
  • Focal/grid laser photocoagulation treatment within 3 months of study entry in the study eye.
  • Panretinal photocoagulation treatment within 3 months of study entry in the study eye.
  • Prior vitrectomy in the study eye
  • History of retinal detachment in the study eye
  • Prior trabeculectomy or other filtration surgery in the study eye
  • Active intraocular inflammation in either eye
  • Active ocular or periocular infection in either eye
  • Active scleritis or episcleritis in either eye
  • History of any other retinal vascular disease (e.g., retinal vein occlusion, retinal artery occlusion) in the study eye.
  • Coexistent retinal disease other than diabetic retinopathy (e.g., AMD (age related macular degeneration), inherited retinal disease) in the study eye.
  • Intraocular surgery within 3 months of study entry in the study eye.
  • History of corneal transplant or corneal dystrophy in the study eye.
  • Significant media opacities in study eye which may interfere with visual acuity in the study eye.
  • Participation as a subject in any clinical study within 3 months of study entry.
  • History of allergy to topical iodine
  • 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

Treatment and study plan

ranibizumab

Drug

Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.

Other names: Lucentis

Primary outcomes

  1. Number of Participants With Non-severe Ocular Adverse Events

    Time frame: 12 months

    As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.

  2. Number of Participants With Severe Ocular Adverse Events

    Time frame: 12 months

    As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs.

  3. Number of Participants With Non-severe Non-ocular Adverse Event

    Time frame: 12 months

    As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.

  4. Number of Participants With Severe Non-ocular Adverse Event

    Time frame: 12 months

    As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.

Secondary outcomes

  1. Mean Change in BCVA

    Time frame: Months 6 and 12

    Mean change in best-corrected visual acuity as assessed by the number of letters read correctly on the electronic ETDRS eye chart from baseline to months 6 and 12.

  2. Mean Change in Central Foveal Thickness

    Time frame: Months 6 and 12

    Mean absolute change from baseline central foveal thickness at months 6 and 12 as measured by SDOCT (defined as the average thickness within the central 1 mm subfield)

  3. Anatomically Dry Eyes by SDOCT

    Time frame: Months 6 and 12

    Number of participants with an anatomically "dry" study eye by SDOCT at months 6 and 12

  4. Gain in Vision Greater Than or Equal to 15 Letters

    Time frame: Months 6 and 12

    Number of participants that gained greater than or equal to 15 letters of vision in their study eye at months 6 and 12.

  5. Loss in Vision Greater Than or Equal to 15 Letters

    Time frame: Months 6 and 12

    Number of participants that lost greater than or equal to 15 letters of vision in their study eye at months 6 and 12.

  6. Participants With BCVA at 20/40 or Better

    Time frame: Months 6 and 12

    Number of participants with 20/40 or better best-corrected visual acuity in their study eye at months 6 and 12.

  7. Number of Participants With Angiographic Leakage

    Time frame: 3, 6 and 12 months

    Number of participants with angiographic leakage in their study eye measured from baseline to months 3, 6 and 12 (i.e. presence of leakage).

  8. Number of Participants With Nonperfusion

    Time frame: 3, 6 and 12 months

    Number of participants with peripheral nonperfusion in their study eye from baseline to months 3, 6, and 12 (i.e. presence of ischemia).

Sponsors and collaborators

Lead sponsor

Justis Ehlers

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Safety and Efficacy of Intravitreal Ranibizumab for Diabetic Macular Edema Previously Treated With Intravitreal Bevacizumab: A Randomized Dual Arm Comparative Dosing Trial

Acronym: REACT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2013
Registry last updated
Nov 3, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.