Intraocular Cytokines in Non-responders to Ranibizumab Treatment for Neovascular AMD

NCT02218177 | Completed

• 1 other identifier: VEGF wAMD cytokine study
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the level of cytokines (which are small proteins important in cell signalling) in eye fluid (aqueous humour) in patients with wet age related macular degeneration patients who have been treated with an injection in the eye (intravitreal injection) with a drug called ranibizumab. The level of cytokines will be compared between patients who have a good response to ranibizumab treatment and patients who are non-responsive to ranibizumab and need other forms of therapy. This knowledge will help for the future treatment and to potentially develop new medication for wet age-related macular degeneration.

Conditions

Age Related Macular Degeneration

Keywords

wet Age Related Macular Degeneration; Ranibizumab; Aflibercept; Combination Photodynamic Therapy; Cytokine analysis

Outcome Measures

Primary Outcomes (1)

• Aqueous Humour Cytokine Levels

  At time of Intravitreal Injection

Secondary Outcomes (5)

• Demographic Data

  At time of appointment

• Number of anti-VEGF injections before developing non-responder characteristics

  At time of appointment

• History of Previous Treatment

  At time of appointment

• Optical Coherence Tomography (OCT) results

  At time of appointment

• Fluorescein Angiography Results and Indocyanine Green Angiography Results

  At time of appointment

Study Arms (3)

Non-responders receiving aflibercept therapy

Non-responders to ranibizumab who are now receiving aflibercept therapy

Drug: Aflibercept

Non-responders receiving PDT combo therapy

patients who are non-responders to ranibizumab who have been switched to combination photodynamic therapy (PDT)

Procedure: Combination Photodynamic Therapy

Responders to ranibizumab

Patients who are responders to ranibizumab and are continuing monthly injections.

Drug: Ranibizumab

Interventions

Aflibercept DRUG

anti-VEGF treatment for wet age related macular degeneration

Also known as: Eylea (R)

Non-responders receiving aflibercept therapy

Ranibizumab DRUG

anti-VEGF treatment for wet age related macular degeneration

Also known as: Lucentis

Responders to ranibizumab

Combination Photodynamic Therapy PROCEDURE

Use of cold laser with an intravitreal injection of dexamethasone to treat wet age related macular degeneration

Non-responders receiving PDT combo therapy

Eligibility Criteria

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

Study Population

Study patients in the treatment group will be those greater than 50 years old, with age related macular degeneration, who are non-responder/ resistance to ranibizumab treatment. Control group will include patients who are responders to ranibizumab treatment.

You may qualify if:

• Age 50 years or more
• Ranibizumab resistance/poor responder patients in all AMD entities (typical AMD, PCV and RAP) who will be treated with intravitreous ranibizumab in combination with verteporfin photodynamic therapy
• Ranibizumab resistance/poor responder patients in all AMD entity (typical AMD, PCV and RAP) who will be treated with intravitreous aflibercept injection
• AMD patient who is good response to the treatment of ranibizumab (control group)

You may not qualify if:

• Any evidence of good response in treatment of ranibizumab,
• Uncooperative patients to intravitreal treatment
• Patients who have clinically active ocular inflammation
• Patients who have previous PDT treatment within 6 months
• Patient who previously have ocular treatment of immunosuppressive agent within 3 months
• Patient who previously have ocular treatment of steroid with in 3 months
• Patients who are currently on systemic treatment of anti-VEGF medication or immunosuppressive agents.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M2N4H3, Canada

Location

Related Publications (1)

• Pongsachareonnont P, Mak MYK, Hurst CP, Lam WC. Neovascular age-related macular degeneration: intraocular inflammatory cytokines in the poor responder to ranibizumab treatment. Clin Ophthalmol. 2018 Sep 26;12:1877-1885. doi: 10.2147/OPTH.S171636. eCollection 2018.

  PMID: 30310267 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aqueous Humour from Eye

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye 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

• Wai-Ching Lam, MD

  Toronto Western Hospital, University Health Network, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor University of Toronto, Residency Program Director Dept. of Ophthalmology, Continuing Medical Education Director Dept. of Ophthalmology

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 18, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

CA (1)