Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

NCT01476449 | Completed Phase 2 Results DMC

• 1 other identifier: 1127228
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetic Retinopathy; Macular Edema

Keywords

Diabetic Macular Edema; Diabetic Retinal Swelling; DIabetic Eye Disease

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline through 24 months

Secondary Outcomes (4)

• Mean Number of Injections.

  24 months

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

  24 months

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

  24 months

• Percentage of Patients Anatomically "Dry."

  24 Months

Study Arms (2)

Monthly Ranibizumab

ACTIVE COMPARATOR

Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.

Drug: Ranibizumab

Treat and Extend Ranibizumab

EXPERIMENTAL

Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

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

Also known as: Lucentis

Monthly Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Retina Vitreous Associates of Florida: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Retina Vitreous Associates of Florida

Clearwater, Florida, 33756, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

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

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

Small sample size, single-center, unmasked trial. This pilot study should be interpreted in the context of these limitations, yet may yield some guidance on one of the more common dosing methods for anti-VEGF medications in DME.

Results Point of Contact

• Title: David Eichenbaum, MD
• Organization: Retina Vitreous Associates of Florida

deichenbaum@retinavitreous.com

727-323-0077

Study Officials

• David Eichenbaum, MD

  Retina Vitreous Associates of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 17, 2019
• Results First Posted: May 17, 2019

Record last verified: 2019-04

Locations

US (2)