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

NCT02127684 | Withdrawn Phase 2

• 1 other identifier: ML29381
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Diabetic Macular Edema

Keywords

diabetic macular edema

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard Dosing Group

ACTIVE COMPARATOR

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

Frequent dosing group

EXPERIMENTAL

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

Interventions

ranibizumab DRUG

ranibizumab 0.3mg intravitreally monthly

Also known as: Lucentis

Standard Dosing Group

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
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maturi, Raj K., M.D., P.C.: lead

Study Sites (1)

Raj K Maturi MD

Indianapolis, Indiana, 46290, United States

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Raj K Maturi, MD

  Raj K. maturi MD PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

US (1)