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

NCT ID: NCT02127684

Last Updated: 2014-07-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2015-11-30

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.

Conditions

Persistent Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ranibizumab

Intervention Type: DRUG

ranibizumab 0.3mg intravitreally monthly

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

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

ranibizumab given every 2 weeks for 8 weeks then monthly as needed

Interventions

ranibizumab

ranibizumab 0.3mg intravitreally monthly

Intervention Type: DRUG

ranibizumab

ranibizumab given every 2 weeks for 8 weeks then monthly as needed

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
• 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.

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

Sponsors

Maturi, Raj K., M.D., P.C.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raj K Maturi, MD

Role: PRINCIPAL_INVESTIGATOR

Raj K. maturi MD PC

Locations

Raj K Maturi MD

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

ML29381

Identifier Type: -

Identifier Source: org_study_id