Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema

NCT04018833 | Completed DMC

• 1 other identifier: 20190701245703984
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetic Macular Edema; Diabetic Retinopathy

Keywords

Diabetic Macular Edema; Bevacizumab; Ranibizumab; Aflibercept; BCVA; OCT

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

ranibizumab

Patients nonresponsive to bevacizumab that were switched to ranibizumab

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

aflibercept

Patients nonresponsive to bevacizumab that were switched to aflibercept

Drug: Aflibercept 40 MG/ML Intraocular Solution [EYLEA]

Interventions

Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS] DRUG

ranibizumab

Aflibercept 40 MG/ML Intraocular Solution [EYLEA] DRUG

aflibercept

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients followed on the ocular diabetes consultation of Centro Hospitalar Universitário do Porto, Portugal, with DME unresponsive or incompletly responsive to intravitreal bevacizumab (1,25 MG/0.05 ML).

You may qualify if:

• 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, defined 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bernardete Pessoa MD: lead

Related Publications (1)

• Pessoa B, Malheiro L, Carneiro I, Monteiro S, Coelho J, Coelho C, Figueira J, Meireles A, Melo Beirao JN. Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema: Exploratory Retrospective Analysis. Clin Ophthalmol. 2021 Jan 22;15:253-260. doi: 10.2147/OPTH.S280644. eCollection 2021.

  PMID: 33519187 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Ranibizumab; aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• João Melo-Beirão, MD, PhD

  Centro Hospitalar do Porto

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: January 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 30, 2016
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share