Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard antiVEGF Dosing

Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard AntiVEGF Dosing

The investigators would like to investigate the efficacy of more frequent treatment with Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen.

Study Overview

• Status: Withdrawn
• Conditions: Persistent Diabetic Macular Edema
• Intervention / Treatment: Drug: ranibizumab; Drug: ranibizumab

Detailed Description

This is an open-label, subject masked, phase II study of intravitreally administered ranibizumab in subjects with persistent diabetic macular edema. Persistent diabetic macular edema is defined as subjects who still have central subfield thickness on SD-OCT of greater than 320 microns after having received at least 3 previous doses of AntiVEGF therapy in the past 5 months. Consented, enrolled subjects will be randomized into two subgroups: (1) standard dosing of monthly 0.3mg ranibizumab or (2) 0.3mg ranibizumab given 2 weeks apart for 5 doses followed by monthly dosing.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Raj K Maturi MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Diagnosis of Type 1 or Type 2 diabetes
• BCVA score using the ETDRS method of >24 and <78 in the study eye at the screening visit
• 3 or more intravitreal injections of AntiVEGF over the 5 months prior to screening
• Presence of diabetic macular edema defined as SD-OCT CST >320 microns on spectral domain machine

Exclusion Criteria:

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

  • Anti-VEGF treatment in the study eye within 3 weeks prior to screening
  • Intravitreal Ozurdex treatment in the study eye within 12 weeks prior to screening
  • Intravitreal steroid treatment in the study eye within 8 weeks prior to screening
  • PRP or focal laser in the study eye within 4 months prior to screening
  • Active iris neovascularization in the study eye
  • Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result.
  • History of cataract surgery in the study eye within 3 months prior to screening visit
  • Uncontrolled systemic disease
  • Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the screening visit
  • Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception.
  • Any condition or reason (including inability to read ETDRS chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study.
  • Known allergy, hypersensitivity or contraindication to the study medications, its components, fluorescein or povidone iodine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard Dosing Group; Standard Dosing Group will receive intravitreal injections of 0.3mg. ranibizumab at baseline, week 4 and 8 )sham injections at week 2 and 6). After week 8 retreatment will be given monthly if edema is greater than 290um or ETDRS visual acuity score <83	Drug: ranibizumab; ranibizumab 0.3mg intravitreally monthly; Other Names: Lucentis; Drug: ranibizumab; ranibizumab given every 2 weeks for 8 weeks then monthly as needed; Other Names: Lucentis
EXPERIMENTAL: Frequent dosing group; Frequent dosing subjects will be evaluated and treated every two weeks through week 8 with intravitreal injection of 0.3mg ranibizumab. Subjects will then be evaluated monthly through week 24 and will receive treatment with ranibiumab based on residual edema and visual acuity	Drug: ranibizumab; ranibizumab 0.3mg intravitreally monthly; Other Names: Lucentis; Drug: ranibizumab; ranibizumab given every 2 weeks for 8 weeks then monthly as needed; Other Names: Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization	mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization	24 weeks

Collaborators and Investigators

• Sponsor: Maturi, Raj K., M.D., P.C.
• Investigators: Principal Investigator: Raj K Maturi, MD, Raj K. maturi MD PC

Study record dates

Study Major Dates

• Primary Completion (ANTICIPATED): August 1, 2015
• Study Completion (ANTICIPATED): November 1, 2015

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (ESTIMATE): May 1, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: diabetic macular edema
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: ML29381