Safety and Efficacy of Ranibizumab for Diabetic Macular Edema

NCT ID: NCT01982435

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-24
• Study Completion Date: 2016-05-26

Brief Summary

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).

Detailed Description

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I - Monthly

Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.

Group Type: OTHER

Ranibizumab

Intervention Type: DRUG

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

Group II - Treat-and-Extend

Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.

Group Type: OTHER

Ranibizumab

Intervention Type: DRUG

Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.

Interventions

Ranibizumab

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

Intervention Type: DRUG

Ranibizumab

Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.

Intervention Type: DRUG

Other Intervention Names

Lucentis; Lucentis

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Justis Ehlers

OTHER

Sponsor Role: lead

Responsible Party

Justis Ehlers

Staff physician / Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Justis Ehlers, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, United States

Cole Eye Institute at Hillcrest Hospital

Mayfield Heights, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

REACT Study

Identifier Type: -

Identifier Source: org_study_id