Analysis of naïve Patients With Age-related Macular Degeneration Neovascular Type and Treated With Ranibizumab (Lucentis®) in Treat-and-extend at the CHU Brugmann.

NCT04988178 | Completed

• 1 other identifier: CHUB- KIERKOWICZ
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50 years old. Neovascular AMD, the most severe form and the most severe is characterized by the appearance, spread and growth of subretinal neovessels. One of the major molecular mediators is the endothelial growth factor vascular (VEGF). Intra-vitreous (IVI) injection of an anti-VEGF may slow the progression of Neovascular AMD and stabilize vision in the majority of cases. Ranibizumab (Lucentis®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD. At the start of its use, ranibizumab was first injected monthly and then according to the "reactive" protocol. Over time, a new strategy of treatment was born: the "treat-and-extend" (T\&E). This is 'made to measure' protocol for each patient aiming to reduce the frequency of injections while guaranteeing inactivity of the disease. It starts with the loading dose, i.e. 3 injections given 4 weeks apart. Subsequently, the interval is lengthened by slices of 1 or 2 weeks provided that the visual and anatomical results remain stable. In the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each IIV. The efficacy and safety of ranibizumab, when used in a proactive regimen of T\&E, has been shown in the CANTREAT randomized controlled trial. However, there is a lack of more data on T\&E used in current practice, and particularly on the number of injections and treatment intervals over a minimum treatment period of 24 months. The aim of this retrospective study carried out at the CHU Brugmann Hospital is to determine the number of injections and the intervals necessary to have encouraging results in visual acuity over a treatment period of at least two years.

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Injections number (first 24 months of treatment)

  Number of injections during the first 24 months of treatment

  first 24 months of treatment

• Injections interval

  Last injection interval during the 2nd year of treatment, in weeks

  during the 2nd year of treatment

Secondary Outcomes (24)

• Injection number (up to 4 years of treatment)

  up to 4 years of treatment

• Injections interval (up to 4 years of treatment)

  up to 4 years of treatment

• Most stable injection interval

  up to 4 years of treatment

• Overall extension interval

  up to 4 years of treatment

• Covid 19 impact

  up to 4 years of treatment

Interventions

Data extraction from medical files OTHER

Data extraction from medical files

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Naive patients with age-related macular degeneration, neovascular type, treated with ranibizumab (Lucentis®) in "treat-and-extend" at the CHU Brugmann Hospital.

You may qualify if:

• Patients\> 50 years old diagnosed with neovascular age related macular degeneration,
• Patients who have never received anti-VEGF treatment,
• Patients who started intra-vitreous injections of ranibizumab between 01 January 2014 and November 30, 2019,
• Treatment by "treat-and-extend" directly after the loading dose of ranibizumab,
• Availability of the medical file reporting treatment with ranibizumab.

You may not qualify if:

• Participation in an interventional clinical study during treatment with ranibizumab,
• Patients suffering from ocular pathologies and having required surgery during the first 24 months of treatment with ranibizumab (for example advanced glaucoma or cataract).

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Laurence Postelmans

  CHU Brugmann

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ophtalmology department

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: August 3, 2021
• Study Start: April 13, 2021
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)