Safety and Efficacy of Ranibizumab for Diabetic Macular Edema

NCT01982435 | Completed Phase 1 Results DMC

• 1 other identifier: REACT Study
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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).

Conditions

Diabetic Macular Edema

Keywords

Diabetes; Macular Edema

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Non-severe Ocular Adverse Events

  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.

  12 months

• Number of Participants With Severe Ocular Adverse Events

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

  12 months

• Number of Participants With Non-severe Non-ocular Adverse Event

  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.

  12 months

• Number of Participants With Severe Non-ocular Adverse Event

  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.

  12 months

Secondary Outcomes (8)

• Mean Change in BCVA

  Months 6 and 12

• Mean Change in Central Foveal Thickness

  Months 6 and 12

• Anatomically Dry Eyes by SDOCT

  Months 6 and 12

• Gain in Vision Greater Than or Equal to 15 Letters

  Months 6 and 12

• Loss in Vision Greater Than or Equal to 15 Letters

  Months 6 and 12

Study Arms (2)

Group I - Monthly

OTHER

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.

Drug: Ranibizumab

Group II - Treat-and-Extend

OTHER

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.

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

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

Also known as: Lucentis

Group I - Monthly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Justis Ehlers: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Cole Eye Institute at Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The relatively small sample size of eyes and short 1 year duration makes it challenging to extrapolate data to generate clinical management guidelines. The lack of a control group is an important limitation to recognize that also limits conclusions.

Results Point of Contact

• Title: Dr. Justis Ehlers
• Organization: Cleveland Clinic Foundation

Ehlersj@ccf.org

216-636-0183

Study Officials

• Justis Ehlers, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff physician / Sponsor-Investigator

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 13, 2013
• Study Start: June 24, 2014
• Primary Completion: May 26, 2016
• Study Completion: May 26, 2016
• Last Updated: November 3, 2020
• Results First Posted: August 1, 2017

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)