Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04018833
Other study ID # 20190701245703984
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date June 30, 2016

Study information

Verified date July 2019
Source Centro Hospitalar do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

PURPOSE: To evaluate the efficacy of switching from bevacizumab to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes with diabetic macular edema (DME) nonresponders to bevacizumab (Avastin; Genentech, South San Francisco, CA).

METHODS: Single-center retrospective comparative study of patients with DME unresponsive to intravitreal bevacizumab that were switched to ranibizumab or aflibercept. Best-corrected visual acuity and central foveal thickness will be analysed prior to and 3 months after the switch. OCT biomarkers will also analyzed.

A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Patients will improve anatomically and functionally after switch.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 30, 2016
Est. primary completion date June 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- type 1 or type 2 diabetes mellitus patients

- older than 18 years

- with center-involved DME, defined as central subfield thickness (CST) of more than 300 µm on spectral-domain OCT (SD-OCT).

- nonresponsive to bevacizumab, de?ned as having persistent intraretinal and/or subretinal fluid on optical coherence tomography (OCT), i.e CSF>300µm after a minimum of 3 monthly injections, 4 months before switch, regardless of visual acuity (VA).

Exclusion Criteria:

- additional ocular diseases that could significantly affect the visual acuity such as:

- significant vitreoretinal interface abnormality on SD-OCT that may contribute to macular edema

- age-related macular degeneration

- retinal vascular occlusion

- central corneal opacity

- amblyopia

- advanced glaucoma

- optic neuropathy

- history of ocular trauma or surgery other than uncomplicated cataract extraction

- cataract surgery within 3 months before or after bevacizumab switch

- unable to provide written informed consent.

Study Design


Intervention

Drug:
Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]

Aflibercept 40 MG/ML Intraocular Solution [EYLEA]


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bernardete Pessoa MD

Outcome

Type Measure Description Time frame Safety issue
Primary Anatomical change The central foveal thickness (CFT), measured by Optical Coherence Tomography, was automatically measured by the software in the central 1 mm. A CFT <250 µm or >300 µm is considered pathological. A CFT between 200 and 300 µm is considered physiological. CFT has no defined minimum or maximum values.
Since patients with diabetic macular edema usually have CFT >300 µm the goal of treatment is to lower the CFT to values between 200 and 300 µm. A clinical significant anatomical improvement was considered for a change in CFT=10%.
Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
Primary Functional change Functional change was measure by the Early Treatment Diabetic Retinopathy Scale (ETDRS) which measures the best-corrected visual acuity with an ETDRS-like chart at 4 meters in number letters or at 1 meter when patients are unable to read any letters on the ETDRS chart at 4 meters. The ETDRS scale varies from 1 to 85 letters (85 letters correspond to a 20/20 in the Snellen scale).
The higher the value the better the outcome. A clinical significant functional improvement was considered for a gain of =5 EDTRS letters.
Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
See also
  Status Clinical Trial Phase
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT03660384 - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy N/A
Completed NCT03660345 - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME Phase 3
Completed NCT04905459 - ARDA Software for the Detection of mtmDR
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT05022615 - Comparing 3 Imaging Systems
Completed NCT00385333 - Metabolic Mapping to Measure Retinal Metabolism Phase 2
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Completed NCT03702374 - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04009980 - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus. N/A
Completed NCT02924311 - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting NCT06257082 - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities N/A
Not yet recruiting NCT05452993 - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography N/A
Withdrawn NCT02812030 - Aflibercept for Retinopathy in the Real World N/A
Completed NCT02391558 - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography N/A
Active, not recruiting NCT02330042 - OCT Biomarkers for Diabetic Retinopathy
Active, not recruiting NCT02353923 - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy N/A
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A