Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

Official title:

Open-label Clinical Trial to Evaluate Safety and Efficacy of Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Non-responders to the Conventional Treatment With Ranibizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136252
• Other study ID #: ZAPA-01/EudraCT 2009-017429-21
• Secondary ID: 2009-017429-21
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2010
• Last updated: March 16, 2012
• Start date: May 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

Adalimumab is a humanized recombinant monoclonal antibody fragment targeted against tumor necrosis factor. This study will assess the safety and efficacy of intravitreal adalimumab administered in patients with choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with intravitreal ranibizumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with ranibizumab (active choroidal neovascularization after loading phase of one injection per month for three consecutive months, followed by a maintenance phase with 5 injections in the last 12 months or 3 injections in the last 6 months

Exclusion Criteria:

• Only one functional eye

• Hypersensitivity to adalimumab or any component of the formulation

• Previous systemic treatment with adalimumab

• Cancer

• Life expectancy <1 year

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• Adalimumab
Intravitreal adalimumab injection (0,1 ml= 50 mcg) in the eye of the included patients. Patients will be followed up every week for a total of 4 weeks, and after every month until 6 months. If it is necessary, repeat the injection every month, maximum three months

Locations

Country	Name	City	State
Spain	Servicio de Oftalmologia. Hospital Universitario Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients proportion with electroretinogram alterations		6 months	Yes
Secondary	Changes in retinal thickness measured by ocular coherence tomography		once a month to 6 months	No
Secondary	Changes in best corrected visual acuity		once a month to 6 months	No
Secondary	Incidence of adverse events		until 6 months	Yes