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

Primary Purpose

Persistent Diabetic Macular Edema

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
ranibizumab
Sponsored by
Maturi, Raj K., M.D., P.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Diabetic Macular Edema focused on measuring diabetic macular edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Raj K Maturi MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Dosing Group

Frequent dosing group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 29, 2014
Last Updated
July 29, 2014
Sponsor
Maturi, Raj K., M.D., P.C.
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1. Study Identification

Unique Protocol Identification Number
NCT02127684
Brief Title
Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard antiVEGF Dosing
Official Title
Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard AntiVEGF Dosing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Withdrawn
Why Stopped
sponsor determined study design would not produce useful results
Study Start Date
undefined (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maturi, Raj K., M.D., P.C.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Diabetic Macular Edema
Keywords
diabetic macular edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Dosing Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Frequent dosing group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
ranibizumab 0.3mg intravitreally monthly
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
ranibizumab given every 2 weeks for 8 weeks then monthly as needed
Primary Outcome Measure Information:
Title
mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization
Description
mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj K Maturi, MD
Organizational Affiliation
Raj K. maturi MD PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raj K Maturi MD
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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