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Protocol FVF3689g: A phase IIIb, Multicenter, study to evaluate the safety and tolerability of ranibizumab in naive and previously treated subjects with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) (IRBMED HUM00002516 )
Age-related macular degeneration (AMD) causes you to lose the central vision in your eye(s) because the part of your retina (inside of your eye) known as the macula degenerates. This degeneration is caused by abnormal blood vessels (neovascularization) growing under the macula and is mostly responsible for your vision loss. Neovascular (wet) AMD is one of the leading causes of vision loss in people 65 years of age and over. The study drug, called ranibizumab under the trade name Lucentis, is given by injection into the eye. Lucentis was approved by the Food and Drug Administration (FDA) on June 30, 2006 for treatment of neovascular (wet) age related macular degeneration (AMD). The ranibizumab injection being administered in this study is not the commercially marketed drug, Lucentis, except in use for Part 2 study patients, after July 31, 2006. Ranibizumab is expected to be very similar in safety and activity to the commercially marketed drug Lucentis, but it is possible that some differences may exist. Because this is not the commercially marketed drug, ranibizumab injection can only be administered to subjects enrolled in Part 1 of this clinical trial, and subjects in Part 2 up until July 31, 2006. Ranibizumab can only be administered under the direction of the doctors who are a part of this trial. Ranibizumab blocks a growth factor that is thought to be involved in formation of abnormal blood vessels responsible for loss of vision in patients with wet AMD. Ranibizumab is a fragment of a humanized antibody and is called rhuFab V2 (recombinant human fragment antibody to vascular endothelial growth factor, version 2).
Contact: Melissa Bergeron, 734-615-8560
Principal Investigator: Mark W. Johnson, M.D., 734-763-5906
Study Sponsor: Genentech, Inc.
Recruitment: Open
Monovision Study (IRBMED HUM00007003)
To evaluate visual outcomes and patient satisfaction following cataract removal with new lenses implanted in the eye to allow monovision, which gives the ability to see clearly at distance in one eye and see clearly for near vision in the other eye.
Contact: Shazhad Mian, M.D.
Principal Investigator: Shazhad Mian, M.D.
Study Sponsor: U-M Kellogg Eye Center
Recruitment: Open
Long-term Follow-up of Keratoconus Graft Recipients (IRBMED HUM00001968)
Corneal transplantation has been performed for nearly 100 years, yet long-term quality of life and graft survival rates are unknown. This is particularly relevant for younger graft recipients, of whom keratoconus is the most prevalent reason for corneal transplantation. Such recipients should know how long their graft will remain clear, barring complications, and how their visual function will be long-term. The purpose of this study is to obtain long-term graft survival and visual function information from patients with keratoconus who underwent corneal transplantation during the 1980 to 1986 period at the University of Michigan.
Contact: Leslie Niziol, (734) 936-9319
Principal Investigator: David Musch, Ph.D.
Recruitment: Open
Many people with corneal diseases may be helped by corneal transplantation (keratoplasty). However, in some cases transplantation and repeated transplantation is unsuccessful. For these patients, a physician can implant a small plastic artificial cornea, called a keratoprosthesis (KPro), which is likely to improve vision. This study evaluates the success of this new device.
Contact: Shahzad I. Mian, M.D., 734-615-5476
Principal Investigator: Shahzad I. Mian, M.D., 734-615-5476
Recruitment: Ongoing
This is a study to determine whether certain measurements such as corneal depth, diameter, and length can be used to predict flap size during LASIK surgery. Such information may help improve clinical outcomes after LASIK.
Contact: Shahzad I. Mian, M.D., 734-615-5476
Principal Investigator: Shahzad I. Mian, M.D., 734-615-5476
Recruitment: Ongoing
This study examines the use of deep corneal transplantation with maintenance of the recipient superficial cornea.
Contact: Cindy Pope, C.O.A., 734-936-8672
Principal Investigator: Alan Sugar, M.D., 734-763-5506
Recruitment: Ongoing
A 12-week, Randomized, Double-Masked, parallel Group Comparison of Xalacom™ Given In The Evening, Xalatan® Given In The Evening, and Timolol Given In The Morning In Subjects With Open Angle Glaucoma or Ocular Hypertension In The United States. (IRBMED HUM00003032)
The purpose of the study is to compare the effectiveness and safety of three medications when treating subjects with glaucoma or ocular hypertension. Glaucoma and ocular hypertension are chronic eye diseases that are associated with an increase of the pressure inside the eye. - Lowering the pressure has been proven effective in slowing the progression of the disease for glaucoma and slowing the progression from ocular hypertension to glaucoma. The three medications to be compared in this study are XalacomÔ, XalatanÒ and Timolol. Xalacom™ is a combination of latanoprost and timolol eye drops. Latanoprost and timolol combined takes advantage of the respective ways these medicines work to control eye pressure. Xalacomä is approved in Canada and Europe for the lowering of eye pressure but has not been approved in the United States. The individual medications in Xalacom™, latanoprost (XalatanÒ) and timolol (various brands) are approved in many countries, including the United States, Canada and countries in Europe. XalatanÒ eye drops are approved for the lowering of increased eye pressure. If you are assigned to the XalatanÒ treatment group, the drug will be given in exactly the same way for which it is approved. Timolol has been widely used to treat elevated eye pressure for those with glaucoma or ocular hypertension.
Contact: Carol J. Pollack-Rundle, B.S., C.O.M.T., 734-763-5874
Principal Investigator: Sayoko E. Moroi, M.D.
Study Sponsor: Pfizer, Inc.
Recruitment: Open
Improving Trabeculectomy Outcome with Human Amniotic Membrane (IRBMED 2005-0063)
Trabeculectomy (also referred to as ‘filtration’) surgery involves creating a new drainage channel for the eye to keep the eye pressure normal or low. The success of trabeculectomy surgery is dependent on preventing scarring around this drainage channel. Mitomycin C is a chemical that is already known to help slow scar formation, but some people scar despite its use. Amniotic membrane is also believed to help prevent the eye from scarring. The purpose of this study is to determine if amniotic membrane may be beneficial in slowing scar tissue formation in individuals who already showed scar formation and failed filtration surgery.
Contact: Pauline Radenbaugh, M.S., 734-615-0435
Principal Investigator: Sayoko E. Moroi, M.D.Sayoko E. Moroi, M.D.
Study Sponsor: Clinical Research Initiatives Program, University of Michigan
Recruitment: Open
Multifocal Visual-evoked Potential in Detecting Early Glaucoma Damage (IRBMED HUM00006900)
The purpose of this study is to compare four methods of measuring vision loss due to glaucoma. These tests will show if there has been damage to your optic nerve, or the outer areas of your retina, and the pattern of damage. These methods are being evaluated so that tests can be developed that provide objective assessment of both visual function and nerve damage.
Contact: Carol J. Pollack-Rundle, B.S., C.O.M.T., 734-763-5874
Principal Investigator: Jennifer S. Weizer, M.D.
Recruitment: Open
This study will determine whether there is a correlation between certain gene variations called single nucleotide polymorphisms in the beta 2 adrenergic receptor and eye pressure and eye fluid circulation response to topical beta blockers and related drugs to treat glaucoma. Study subjects who do not have glaucoma will provide cheek swab samples for DNA analysis and undergo fluorophotometry studies to study the circulation of eye fluid. Fluorophotometry is a non-invasive test.
Contact: Pauline Radenbaugh, M.S., 734-615-0435
Principal Investigator: Sayoko E. Moroi, M.D., Ph.D., 734-763-3732
Study Sponsor: Midwest Eye Banks and Transplantation Center
Recruitment: We are not actively recruiting at this time.
Patients will undergo an ocular exam including an assessment of tear drainage, and the patient's parent or legal guardian will complete a questionnaire on the patient's symptoms and quality of life. Patients will be randomized to either balloon catheter dilation or nasolacrimal intubation. Patients who have both eyes enrolled in the study will have the right eye randomized to either balloon catheter dilation or nasolacrimal intubation and the left eye will receive the alternate treatment. Patients aged 6 months - <4 years of any race or gender who have clinical signs of nasolacrimal duct obstruction and a history of failed simple probing will be eligible. A project specific informed consent as well as a University of Michigan surgical consent form will be used.
Follow up consists of the following visits:
- 1-month outcome visit - timed 1 month from the date of surgery or tube removal
- 6-month outcome visit - timed 6 months following surgery
At the follow up visits, an assessment for persistent NLDO will be performed. The parent or legal guardian will complete a questionnaire on the child's symptoms and quality of life. Additional visits are at investigator discretion. All surgical procedures are consistent with standard care. The surgical center is not engaged in the research and no data will be collected by surgical personnel. Data submitted to the Jaeb center will use a specific code number and a secure web site, however the records are linkable to the subject. This study is being conducted in conjunction with the Pediatric Eye Disease Investigator Group (PEDIG), a collaborative research network.
Contact: Erika M. Levin, M.D., 734-936-9503
Principal Investigator: Erika M. Levin, M.D., 734-936-9503
Study Sponsors: National Institute of Health and the Jaeb Center for Health Research
Recruitment: Open
An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia (ETS1)
The Esotropia Treatment Study 1 (ETS1) is an observational study with the objectives of 1) determining the duration of misalignment in infantile esotropia (ET), acquired non-accommodative esotropia (ANAET), and acquired partially-accommodative esotropia (APAET) at study enrollment, 2) prospectively establishing the proportion of patients with angle instability in infantile ET, ANAET, and APAET, and 3) determining recruitment potential for a randomized trial.
A repeat measurement of alignment will be performed at the 6-week and 12-week visits as part of a test-retest ancillary study with the following objectives:
- to determine the interobserver test-retest variability of angle misalignment
- to determine the interobserver test-retest variability of a change in angle misalignment
- to use these test-retest data to define a change in angle alignment that exceeds an amount which could reasonably be due to measurement error
Subjects will be children less than 5 years old of random race or gender. This study is being conducted in conjunction with the Pediatric Eye Disease Investigator Group (PEDIG), a collaborative research network.
Contact: Erika M. Levin, M.D., 734-936-9503
Principal Investigator: Erika M. Levin, M.D., 734-936-9503
Study Sponsors: National Institute of Health and the Jaeb Center for Health Research
Recruitment: Open
Multicenter Uveitis Steroid Treatment (MUST) Trial Protocol (IRBMED HUM00001490)
The primary objective of the Multicenter Uveitis Steroid Treatment (MUST) Trial is to compare the effectiveness of standard treatment (oral medication) versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis or panuveitis.
Patients with active uveitis will be randomized, with a 1:1 allocation ratio, to treatment with either the fluocinolone acetonide implant (a small device implant that contains medication) or standard treatment (oral medication) consisting of oral corticosteroids and supplementary immunosuppressive drugs when indicated, according to standardized guidelines.
Contact: Julie Gothrup, 734-936-9798
Principal Investigator: Susan Elner, M.D.
Study Sponsor: National Eye Institute of the National Institutes of Health
Recruitment: Open
Vitreous Penetration of Orally Administered Famciclovir and Valacyclovir (IRBMED HUM00001386)
This study will help to determine whether anti-viral drugs can penetrate into the fluid in the eye when taken orally. Patients who need to undergo vitrectomy and are 18 years or older could be eligible.
Contact: Tony H. Huynh, M.D., 734-764-5208
Principal Investigator: Mark W. Johnson, M.D.
Recruitment: Closed
Prevalence of Obstructive Sleep Apnea in Patients with Central Serous Chorioretinopathy (IRBMED HUM00003666)
This research study is to determine whether there is an association between an eye disease called central serous chorioretinopathy and a breathing disorder called obstructive sleep apnea. Any adult patients diagnosed with central serous retinopathy (a condition of fluid leakage in the back of the eye which decreases vision), the retinal condition being studied, and patients without a history of any retinal disease may be eligible to participate.
Contact: Garrett Scott, M.D., 734-764-5208
Principal Investigator: Thellea Leveque, M.D, M.P.H., 734-763-1415
Study Sponsor: University of Michigan General Clinical Research Center
Recruitment: Open
Sleep Apnea as a Potential Risk Factor for Central Serous Chorioretinopathy (IRBMED 2004-0583)
This project will use a survey instrument to determine the approximate prevalence of sleep apnea in a CSCR population compared to published data on sleep apnea prevalence in normals. If the rate of sleep apnea is high in patients with CSCR, the possibility exists that sleep apnea is a risk factor for CSCR. If sleep apnea predisposes patients to develop CSCR, perhaps treatment of the apnea could ameliorate or prevent recurrences of CSCR.
An alternate explanation of such a correlation would be that the two diseases share a common risk factor. If an association between the diseases were identified, a sleep-study based, risk factor controlled project would be warranted in order to be certain of the sleep apnea diagnosis, and to eliminate confounding variables.
Contact: Thellea Leveque, M.D, M.P.H., 734-763-1415
Principal Investigator: David N. Zacks, M.D., Ph.D.
Recruitment: Open
A Study of Encapsulated Cell Technology Implant for Participants with Early Stage Retinitis Pigmentosa (IRBMED HUM00010845)
This study will assess the safety and effectiveness of ciliary neurotrophic factor (CNTF) implants in patients with retinitis pigmentosa, Usher Type II III, and choroideremia. Currently there are no effective therapies for people with these retinal degenerations. They are genetic disorders that affect night vision and later cause tunnel vision and loss of central vision.
The implant is a small capsule that contains human retinal pigment epithelium cells. These cells have been given the ability to make CNTF, which they release through the capsule membrane into the surrounding ocular fluid. In this study, two different CNTF dose levels will be used: a high dose and a low dose in one eye, as well as a sham (placebo) surgery in the other eye.
Eligibility criteria:- to men and women between 18 and 64 years
- patients with a diagnosis of RP, Usher Syndrome Type II or III, or choroideremia
- individuals whose visual acuity is no worse than 20/63
- individuals who have had at least two full-threshold Humphrey Visual Field 30-2 tests, one completed within the year before enrolling in this study
Exclusion criteria:
- women who are pregnant or breastfeeding or who do not use contraception
- individuals with other eye diseases, including advanced cataract
- individuals with RP caused by a classic syndrome, including Usher Type I
- individuals with a chronic systemic disease that requires treatment with systemic steroids, immunosuppressive medications or insulin
Contact: Pam Titus, 734-763-5906
Principal Investigator: John R. Heckenlively, M.D.
Study Sponsor: Neurotech Pharmaceuticals
Recruitment: Open
A Study of Encapsulated Cell Technology Implant for Participants with Late Stage Retinitis Pigmentosa (IRBMED HUM00010845)
This study will assess the safety and effectiveness of ciliary neurotrophic factor (CNTF) implants in patients with retinitis pigmentosa, Usher Type II III, and choroideremia. Currently there are no effective therapies for people with these retinal degenerations. They are genetic disorders that affect night vision and later cause tunnel vision and loss of central vision.
The implant is a small capsule that contains human retinal pigment epithelium cells. These cells have been given the ability to make CNTF, which they release through the capsule membrane into the surrounding ocular fluid. In this study, two different CNTF dose levels will be used: a high dose and a low dose in one eye, as well as a sham (placebo) surgery in the other eye.
Eligibility criteria:
- men and women between 18 and 64 years
- patients with a diagnosis of RP, Usher Syndrome Type II or III, or choroideremia
- individuals whose visual acuity is no better than 20/80 and no worse than 20/320
- individuals who have reduced electrical responses from the retina (ERG) and loss of peripheral vision
Exclusion criteria:
- women who are pregnant or breastfeeding or who do not use contraception
- individuals with other eye diseases, including advanced cataract
- individuals with RP caused by a classic syndrome, including Usher Type I
- individuals with a chronic systemic disease that requires treatment with systemic steroids, immunosuppressive medications or insulin
Contact: Pam Titus, 734-763-5906
Principal Investigator: John R. Heckenlively, M.D.
Study Sponsor: Neurotech Pharmaceuticals
Recruitment: Open
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