Optic Nerve Diseases Clinical Trial
Official title:
Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Six Weeks Or Greater
Verified date | June 2015 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To understand and characterize the effects of linezolid on the optic nerve by observing and following patients who have been treated with linezolid for six weeks or longer for the development of signs or symptoms of visual disturbance or eye disorders.
Status | Terminated |
Enrollment | 34 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male and female subjects who are 18 years of age or older. - Subjects in Treated Group: - Subjects must have received linezolid 600 mg BID for six weeks or greater and be currently on drug (or have received linezolid within 7 days of baseline evaluation). - Subjects who have current signs or symptoms compatible with linezolid toxicity (i.e. optic or peripheral neuropathy) may be enrolled in the study if they are on linezolid at time of baseline evaluation (or have received linezolid within 7 days of baseline evaluation). - Linezolid may be discontinued at any time at the primary physician's discretion and remain on the study. - Women of childbearing potential must use adequate contraception - Subjects in Control Group: - Subjects will have a diagnosis similar to patients in the treated group and similar important co-morbidities and epidemiologic factors if possible. Exclusion Criteria: - Subject in Treated Group: - Subjects with a known presence of optic or peripheral nerve damage due to another illness, condition or medication. - Subjects with a pre-existing or a diagnosis at time of screening visit of an ophthalmologic condition that would adversely affect the study testing protocol (e.g. dense cataracts, macular degeneration, retinitis pigmentosa). - Subjects who are currently receiving or anticipated to receive another medication, antibiotic or other, that has known potential to produce ocular or neurologic toxicity indistinguishable from that caused by linezolid or lactic acidosis. - Subjects with a history of significant exposure, in the opinion of the investigator and with prior discussion with the medical monitor, to medications known to produce optic or peripheral neuropathy. - Subjects with an active communicable disease (i.e., tuberculosis assessed as currently communicable) and subjects on active treatment for tuberculosis or other mycobacterial disease that include drugs that have known potential to produce ocular or neurologic toxicity. - Subjects with severe liver disease or abnormal liver function test. - Subjects in Control Group: - Subjects must not currently be taking linezolid or have received it for more than 7 days at any time. - Subjects with a known presence of optic or peripheral nerve damage due to another illness, condition or medication. - Subjects with a pre-existing or a diagnosis at the screening visit of an ophthalmologic condition that would adversely affect the study testing protocol (e.g. dense cataracts, macular degeneration, retinitis pigmentosa). - Subjects who are currently receiving another medication, antibiotic or other, that has known potential to produce ocular or neurologic toxicity indistinguishable from that caused by linezolid or lactic acidosis. - Subjects with a history of significant exposure, in the opinion of the investigator and with prior discussion with the medical monitor, to medications known to produce optic or peripheral neuropathy. - Subjects with an active communicable disease (i.e., tuberculosis assessed as currently communicable) and subjects on active treatment for tuberculosis or other mycobacterial disease that include drugs that have known potential to produce ocular or neurologic toxicity. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Universitaria di San Martino | Genova | |
Italy | Ospedale San Martino, Clinica Malattie Infettive | Genova | |
Italy | Università di Genova | Genova | |
Italy | Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia | Udine | |
Sweden | Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge | Stockholm | |
United States | Henry Ford Health System | Detroit | Michigan |
United States | St. Bernards Research Center | Jonesboro | Arkansas |
United States | University of Minnesota, Department of Medicine/Division of Infectious Diseases | Minneapolis | Minnesota |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Drexel University College of Medicine, Partnership Comprehensive Care Practice | Philadelphia | Pennsylvania |
United States | Associates in Infectious Disease and Tropical Medicine | Pittsburgh | Pennsylvania |
United States | Triple O Research Institute, PA | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Italy, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With an Adverse Event | Through and including 28 calendar days after the last administration of the investigational product | Yes | |
Secondary | Percentage of Participants by Clinical Outcome of Infection at End of Study | Clinical response was evaluated at the End of Study visit (30 days after last dose) as Cure, Improvement, Failure, Unknown or Other. Clinical response was based primarily on the global assessment of the clinical presentation of the subject made by the investigator at that evaluation timepoint. The clinical response classifications were defined as follows. Cure: Resolution of the clinical signs and symptoms of infection, when compared to Baseline. No additional antimicrobial treatment is required for the disease under study. Improvement: Improvement in 2 or more, but not all, of the clinical signs and symptoms of infection, when compared with Baseline. No additional antimicrobial treatment is required for the disease under study. Failure: Persistence or progression of Baseline clinical signs and symptoms of infection, or development of new clinical findings consistent with active infection. Unknown: Inability to assess clinical response. | At End of Study visit | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05130385 -
High Resolution Optical Coherence Tomography
|
||
Terminated |
NCT01422525 -
Changes of the Peripapillary Retinal Nerve Fiber Layer After Filtration Surgery in Glaucoma Patients
|
N/A | |
Completed |
NCT01270126 -
Trial of Alternating Current Stimulation in Optic Neuropathy
|
N/A | |
Not yet recruiting |
NCT04289909 -
Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS)
|
N/A | |
Active, not recruiting |
NCT02376881 -
Erythropoietin in Methanol Associated Optic Neuropathy: A Phase-2 Clinical Trial (EPO-MAON Study)
|
Phase 3 | |
Completed |
NCT04125043 -
Accuracy of the Red Reflex Test in the Pediatric Population
|
||
Completed |
NCT02582164 -
Long-Working Distance OCT for Children
|
N/A | |
Recruiting |
NCT06139523 -
Optimize Pediatric OCT Imaging
|
||
Completed |
NCT01404247 -
Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates
|
Phase 1 | |
Recruiting |
NCT05626426 -
Electrical Stimulation for the Treatment of Optic Neuropathies
|
N/A | |
Completed |
NCT04891211 -
Retinal Changes in Vitamin D Deficiency
|
N/A | |
Completed |
NCT01280877 -
Paraorbital-Occipital Alternating Current Stimulation Therapy for Optic Neuropathy (MCT_optnerve)
|
N/A | |
Recruiting |
NCT04634383 -
A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness
|
N/A |