Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema

NCT02924311 | Completed

• 1 other identifier: 18636
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients). This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.

Conditions

Diabetic Retinopathy

Keywords

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients

  At baseline and 12 months

Secondary Outcomes (27)

• Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population

  At baseline and 12 months

• Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups

  At baseline and 24 months

• Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups

  At baseline and 12 months

• Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups

  At baseline and 24 months

• Type of the previous treatment(s) in previously treated patients

  At baseline

Other Outcomes (4)

• Number of prior treatments (DME Monitoring)

  Up to 24 months

• Number of patients with prior photocoagulation laser therapy (DME Monitoring)

  Up to 24 months

• Number of patients with prior anti-VEGF treatment (DME Monitoring)

  Up to 24 months

Study Arms (3)

Previously treated patient

Already treated with any other treatment such as an anti-VEGF agent (other than IVT aflibercept), macular laser photocoagulation (laser), intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Naïve patient

Not previously treated with an anti-VEGF agent, macular laser photocoagulation (laser) or intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Entire study population

Already treated patient with any other treatment such as an anti-VEGF agent (other than intravitreal aflibercept), macular laser photocoagulation, intravitreal steroid injection and initiating treatment with intravitreal aflibercept and not previously treated patients with an anti-VEGF agent, macular laser photocoagulation or intravitreal steroids injection and initiating treatment with intravitreal aflibercept

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) DRUG

Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.

Entire study population; Naïve patient; Previously treated patient

Eligibility Criteria

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

Study Population

Treatment naïve and previously treated diabetic macular disease patients initiating a treatment with intravitreal aflibercept. The prescription of the medicines is clearly separated from the decision to include the patient in the study

You may qualify if:

• Man or woman aged 18 years or older
• Patient diagnosed with a visual impairment due to diabetic macular disease (as defined by HAS (Haute Autorité de Santé) recommendation).
• Patients in whom a decision to treat with intravitreal aflibercept has been made independently of the patient enrollment in the study
• Patient diagnosed with type 1 or 2 diabetes mellitus
• Patient who has been given appropriate information about the study and who has given his/her written, informed consent

You may not qualify if:

• Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept
• Systemic use of any anti / pro VEGF therapy (VEGF: Vascular Endothelial Growth Factor)
• Patient taking part in an interventional study

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, France

Location

Related Publications (1)

• Korobelnik JF, Daien V, Faure C, Tadayoni R, Giocanti-Auregan A, Dot C, Kodjikian L, Massin P; APOLLON study investigators. Two-year outcomes of the APOLLON observational study of intravitreal aflibercept monotherapy in France in patients with diabetic macular edema. Sci Rep. 2022 Oct 29;12(1):18242. doi: 10.1038/s41598-022-22838-1.

  PMID: 36309572 RESULT

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

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

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: October 5, 2016
• Study Start: September 21, 2016
• Primary Completion: August 12, 2019
• Study Completion: December 6, 2019
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

FR (1)