Persistent Diabetic Macular Edema Clinical Trial
Official title:
Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard AntiVEGF Dosing
| Verified date | July 2014 |
| Source | Maturi, Raj K., M.D., P.C. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Raj K Maturi MD | Indianapolis | Indiana |
| Lead Sponsor | Collaborator |
|---|---|
| Maturi, Raj K., M.D., P.C. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |