Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration

NCT02843490 | Completed Phase 4

• 1 other identifier: 469055
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies during the last years reported the involvement of anti-retinal autoantibodies in ocular disorders, such as AMD. These studies support the growing evidence of an immunological involvement in the pathogenesis of AMD. In the planned trial it is planned to enroll 70 subjects, i.e. 50 subjects with neovascular AMD and 20 healthy volunteers. The investigators will evaluate the change from Baseline (Visit 1) in BCVA score at Week 12 (visit 4) in the study eye of nAMD patients treated with Ranibizumab. Neovascular AMD patients (group 1) will be accompanied for 6 months and blood samples will be collected at baseline and monthly until Visit 7 for analysis of antibody profiles. Healthy volunteers (group 2) will be enrolled and a blood sample will be collected once for analysis of antibody profiles. Antibody profiles of all study participants will be analysed to address questions as defined in the outcome measures.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

neovascular age-related macular edema; biomarker; ranibizumab; lucentis

Outcome Measures

Primary Outcomes (1)

• Change in BCVA

  Change from Baseline (Visit 1) in BCVA score at Week 12 (visit 4) in the study eye.

  Baseline - 12 weeks

Secondary Outcomes (3)

• Change in BCVA

  Baseline - 24 weeks

• Change in retinal thickness

  Baseline - 24 weeks

• Number of ranibizumab injections

  24 weeks

Other Outcomes (3)

• Identification of biomarkers against retinal antigens

  24 weeks

• Validation of biomarkers

  24 weeks

• Correlation of functional and structural parameters

  24 weeks

Study Arms (2)

Ranibizumab treatment of nAMD patients

EXPERIMENTAL

nAMD patients will be treated with Ranibizumab (0.5 mg injection) 3 times within three months followed by individual therapy interval based on the clinical progress (PRN) up to 7 times. Analysis of specific biomarker.

Drug: Ranibizumab

healthy subjects

NO INTERVENTION

Analysis of specific biomarker.

Interventions

Ranibizumab DRUG

Three injections (o.5 mg Ranibizumab) within the first three months is followed by an individual therapy interval based on the clinical progress (PRN)

Also known as: Lucentis

Ranibizumab treatment of nAMD patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age ≥ 50 years
• Subfoveal, juxtafoveal and/or extrafoveal choroidal neovascularisation due to neovascular age-related macular degeneration in the study eye
• Visual acuity of 20/400 (ETDRS charts) or better in the study eye
• Ability of subject to understand character and individual consequences of clinical Trial
• Signed and dated informed consent of the subject must be available before start of any specific trial procedures
• Women with childbearing potential have to practice a medically accepted contraception during trial and a negative pregnancy test (urine) should be existent before trial. Reliable contraception are systematic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicide. Women that are sterile by surgery or for more than two years postmenopausal can participate in the trial.
• Male or female
• Age ≥ 50 years

You may not qualify if:

• Inability to obtain fluorescein angiography
• Ophthalmic Surgery or laser \< 3 months before enrolment in one or both eyes
• Any history of intravitreal steroids in one or both eyes
• Systemic and/or intravitreal anti-VEGF-treatment \< 3 months before enrolment in one or both eyes
• Patients with hypersensitivity against ranibizumab
• Ocular inflammation (including trace or above) or external ocular inflammation in the study eye
• Inability to give informed consent to participate in the study
• Pregnancy and lactation; Woman who are of childbearing age and not using medically acceptable effective contraception.
• Medical or psychological condition that would not permit completion of the trial or signing of informed consent (legal representative accepted)
• Participation in other clinical trials including an investigational drug or device during the present clinical trial or within the last 4 weeks.
• Ophthalmic Surgery or laser \< 3 months before enrolment
• Relevant eye diseases except age-related cataract in one or both eyes
• Inability to give informed consent to participate in the study
• Pregnancy and lactation; Woman who are of childbearing age and not using medically acceptable effective contraception.
• Medical or psychological condition that would not permit completion of the trial or signing of informed consent (legal representative accepted)

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Novartis: collaborator

Study Sites (1)

Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Christina Korb, MD

  Johannes Gutenberg-University Mainz, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Med.

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 25, 2016
• Study Start: August 5, 2016
• Primary Completion: August 17, 2017
• Study Completion: November 9, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)