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

• Status: Withdrawn
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maturi, Raj K., M.D., P.C.
• Treatments: Ranibizumab

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.