Clinical Trials

Completed Clinic Trials

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.

VERTACL: Multi-Center, Randomized, Phase II/III Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide as an Adjunct to Photodynamic Therapy in Participants with Neovascular Age-Related Macular Degeneration
This study is to compare the efficacy of treating neovascular (wet) age-related macular degeneration (AMD) with a combination of an intravitreal steroid injection and verteporfin-photodynamic therapy and verteporfin-photodynamic therapy alone. Three hundred participants, 50 years of age or older with wet AMD undergoing verteporfin-photodynamic therapy, will be randomly assigned to receive a sham (no drug), 1 mg or 4 mg intravitreal steroid injection. Depending on the participant's response, treatments may be repeated at 3-month intervals (no more than 8). Participants will complete a maximum of 2 years of follow-up: approximately 11 study visits during total participation.
Principal Investigator: Mark W. Johnson, M.D., 734-936-7760
Study Sponsor: National Eye Institute

An A Phase IIIb, Single-Masked, Multicenter, Randomized Study to Evaluate the Safety and Tolerability of Ranibizumab in Naïve and Previously Treated Subjects with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Contact: Melissa Bergeron, C.O.A., 734-615-8560
Principal Investigator: Mark W. Johnson, M.D., 734-936-7760
Study Sponsor: Genentech, Inc.

A Prospective Multicenter Clinical Trial of the VisionCare Ophthalmic Technologies Implantable Miniaturized Telescope (IMTtm) in Patients with Central Vision Impairment Associated with Age-related Macular Degeneration and Other Maculopathies
This study will test the safety and effectiveness of a miniature telescope implanted in the eye following removal of the lens, in patients with low vision. Patients must experience improvement in their vision with an external telescope to be a candidate for this study and have low vision due to macular degeneration or other macular diseases.
Contact: Carol L. Standardi, R.N. 734-936-7913
Principal Investigator: Paul R. Lichter, M.D., 734-763-1415
Study Sponsor: VisionCare Ophthalmic Technologies, Inc.

Cornea and External Disease Trials

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.
Principal Investigator: Shazhad Mian, M.D.
Study Sponsor: U-M Kellogg Eye Center

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.
Principal Investigator: David Musch, Ph.D.

Keratoprosthesis: Alternative to Keratoplasty (IRBMED 2002-0987)
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.
Principal Investigator: Shahzad I. Mian, M.D.

Corneal Flap Dimension Predictability in Laser in situ Keratomileusis with the Hansatome Microkeratome
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.

Endothelial Keratoplasty Group (EKG)/Deep Lamellar Endothelial Keratoplasty
This study examines the use of deep corneal transplantation with maintenance of the recipient superficial cornea.
Principal Investigator: Alan Sugar, M.D.

Synergeyes vs. Toric Soft Lenses, A Visual Quality of Life Study (IRBMED HUM0000622)
The purpose of this study is to evaluate vision-related quality of life differences for two different modes of correcting myopic astigmatism. The two different modes of correction are: 1) Synergeyes - A hybrid lens design having a rigid gas-permeable center surrounded by a soft periphery. 2) Toric Soft Disposable lenses. This will be a cross-over study where each patient experiences both modalities.
Principal Investigator: Michael Lipson O.D. FAAO
Study Sponsor: SynergEyes, Inc.

Stabilizing Myopia By Accelerated Reshaping Technique (IRBMED HUM00008904)
The intent of this investigation is to determine if wearing Reverse Geometry Rigid Gas Permeable (OCR) lenses on an overnight basis stops or slows the progression of myopia in children as compared to soft disposable contact lens. During the five year evaluation this investigation will compare the subject's feelings of vision and comfort with corneal reshaping lens wearers versus the soft lens wearers.
Principal Investigator: Michael Lipson O.D. FAAO
Study Sponsor: EyeVis LLC.

The effect of hinge position and hinge width on corneal sensation and dry eye after IntraLase LASIK
LASIK surgery requires making a flap in the cornea. The flap is circular but remains partially attached to the cornea at the hinge. The hinge holds the flap in place. The flap can be made with a laser or with a blade. The laser used to make the flap is called the IntraLase. With the IntraLase laser flap, the attachment or hinge can be made smaller or larger. The position of the attachment or hinge can also be made at the top, towards the nose or in between. LASIK surgery temporarily leads to a decrease in corneal sensation and dry eye after surgery. This tends to improve over weeks to months after surgery. The purpose of this study is to determine whether changing the position or the size of the hinge of the LASIK flap made with the IntraLase laser may decrease the loss of corneal sensation and dry eyes following IntraLase LASIK surgery.

Patients who are considered good candidates for IntraLase LASIK surgery to treat myopia (nearsightedness), hyperopia (farsightedness) with and without astigmatism are eligible for this study. Patients are age 20 years or older with normal eyes except for the presence of myopia and hyperopia with or without astigmatism, who are considered for LASIK surgery. Patients with some types of general body diseases such as some arthritis related conditions (systemic collagen vascular diseases, autoimmune disease), or who are pregnant or nursing will be excluded. A discount of $100 towards the cost of the procedure for each eye will be given.
Contact: Cindy Pope, C.O.A., 734-936-8672
Principal Investigator: Shahzad I. Mian, M.D., 734-615-5476

Genotype-based Patient Care for Corneal Stromal Dystrophies
Thus far, there are four different genes identified that carry mutations in patients with corneal stromal dystrophies. Using patients' blood samples for DNA, this study will test the association of specific mutations with the clinical features of the disease, including response to treatment. It will help determine if mutational patterns can be used to predict clinical course before and after surgery, and may help determine the best timing and type of surgical treatment.
Contact: Shahzad I. Mian, M.D., 734-615-5476
Principal Investigator: Shahzad I. Mian, M.D., 734-615-5476

Glaucoma Trials

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 Xalacom®, Xalatan™ 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 (Xalatan™) and timolol (various brands) are approved in many countries, including the United States, Canada and countries in Europe. Xalatan™ eye drops are approved for the lowering of increased eye pressure. If you are assigned to the Xalatan™ 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.
Principal Investigator: Sayoko E. Moroi, M.D.
Study Sponsor: Pfizer, Inc.

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.
Principal Investigator: Sayoko E. Moroi, M.D.
Study Sponsor: Clinical Research Initiatives Program, University of Michigan

Pharmacogenetics and Glaucoma Therapeutics
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.
Principal Investigator: Sayoko E. Moroi, M.D., Ph.D., 734-763-3732
Study Sponsor: Midwest Eye Banks and Transplantation Center

Travatan 0.004% Phase IV and Pharmacogenetics Study in Patients with Open-angle Glaucoma or Ocular Hypertension
This study will help determine the intraocular pressure (IOP) or IOP-lowering effectiveness of the glaucoma drug, Travatan. In addition, this study will examine whether gene variations called single nucleotide polymorphisms in the specific drug target relate to the ability to lower IOP.
Contact: C.J. Pollack-Rundle, C.O.M.T., 734-936-9805
Principal Investigator: Sayoko E. Moroi, M.D., Ph.D., 734-763-3732
Study Sponsor: Alcon Pharmaceuticals

Collaborative Initial Glaucoma Treatment Study
This is a multicenter trial that has been underway for 10 years. It evaluates the various initial treatments for patients with newly diagnosed glaucoma. The goal is to determine whether it is better for the patient's vision and the patient's quality of life to undergo surgery, medication, or laser surgery when trying to lower the intraocular pressure. After five years of follow-up, it appears that either medication or surgery are equally effective treatments. Researchers believe that longer-term follow-up will provide a better basis for recommending the best approach to initial glaucoma treatment.
Principal Investigator: Paul R. Lichter, M.D., 734-763-1415
Co-Principal Investigator & Coordinating Center Director: David C. Musch, Ph.D., M.P.H., 734-763-8175
Study Sponsor: Allergan

Neuro-Ophthalmology Trials

Thus far, results indicate that visual recovery begins rapidly in most patients without any treatment and improvement continues for up to a year. Treatment with high-dose intravenous corticosteroids followed by oral corticosteroids accelerated visual recovery but provided no long-term benefit to vision. Treatment with standard-dose oral prednisone alone did not improve visual outcome and was associated with an increased rate of new attacks of optic neuritis.
Contact: Sharon Boyk, C.O.T., 734-936-8666
Principal Investigator: Jonathan D. Trobe, M.D., 734-763-9147
Study Sponsor: National Eye Institute, NIH

Pediatric Ophthalmology Trials

Nasolacrimal Duct Obstruction Study (NLD2) - A Randomized Trial Comparing Balloon Catheter Nasolacrimal Dilation of Nasolacrimal Intubation for the Treatment of Persistent Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
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 Institutes of Health and the Jaeb Center for Health Research
Recruitment: Closed

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 Institutes of Health and the Jaeb Center for Health Research
Recruitment: Closed

Nasolacrimal Duct Obstruction Study (NLD1) - A Prospective Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
The study has been designed as an observational study that approximates standard clinical practice for patients undergoing a primary procedure for NLDO. All procedures are consistent with standard care with the exception of a questionnaire which the patient's parent will complete at each study visit on NLDO symptoms and quality of life. The investigator will choose the procedure to be performed. Study visits and procedures are the same as if the subject were not in the study. Children of any race or gender ages 6 - < 48 months with clinical nasolacrimal duct obstruction (tearing, mattering of lashes, discharge) are eligible to participate. Records will be linkable to the subject, but the data is sent through a secure website using a unique patient code. A comprehensive, project-specific informed consent will be employed. This study is being conducted in conjunction with the Pediatric Eye Disease Investigator Group (PEDIG), a collaborative research network.
Principal Investigator: Erika M. Levin, M.D., 734-936-9503
Study Sponsors: National Institute of Health and the Jaeb Center for Health Research

Myopic Shift in Pseudophakic vs. Aphakic Pediatric Cataract Patients
This is a retrospective chart review to examine changes in refraction in young patients who undergo cataract surgery with and without intraocular lens implantation.
Contact: Steven M. Archer, M.D., 734-764-4163
Principal Investigator: Steven M. Archer, M.D., 734-764-4163

A Twelve-week, Multicenter, Double-masked, Parallel Group Primary Therapy Study of the Safety and Efficacy of BETOXIN 0.5% Compared to AZOPT 1% in Pediatric Patients with Glaucoma or Ocular Hypertension
This study tests whether Betoxin and Azopt, which are both FDA-approved for use by adults, are effective for children with high intraocular pressure.
Contact: Dannielle Smail, 734-764-7558
Principal Investigator: Monte A. Del Monte, M.D., 734-764-4163
Study Sponsor: Alcon Laboratories

A Twelve-week, Multicenter, Double-masked, Parallel Group Primary Study of the Safety and Efficacy of BETOXIN 0.25% Compared to Timolol Gel Forming Solution 0.25% and 0.5% in Pediatric Patients with Glaucoma or Ocular Hypertension
This study compares three treatments, Betoxin, and two dose levels of Timolol Gel Forming Solution, to determine their ability to control ocular hypertension in children with glaucoma or elevated intraocular pressure.
Contact: Dannielle Smail, 734-764-7558
Principal Investigator: Monte A. Del Monte, M.D., 734-764-4163
Study Sponsor: Alcon Laboratories

A study to test the hypothesis that the anti-fibrotic, anti-inflammatory, and anti-angiogenic properties of amniotic membrane improve trabeculectomy outcome
This study will provide prospective data on the use of amniotic membranes in children with glaucoma to improve trabeculectomy outcomes.
Contact: Maya Eibschitz, M.D., 734-844-2040
Principal Investigator: Maya Eibschitz, M.D., 734-844-2040

A study to improve the care of children with cataracts
While the use of IOLs has the potential to substantially improve the care children with cataracts receive by reducing their reliance on strong glasses or contacts, it is imperative to develop a national standard for measuring a child’s vision capabilities so that the correct strength of lens is used. Maya Eibschitz, M.D., is working to create these measurement models so that ophthalmologists no longer have to rely on measurement methods developed for adults. A child’s maturing eye is not a miniature version of a fully developed eye, having different size and length characteristics. Better lens selection could both decrease the number of surgeries children with cataracts must undergo as they grow as well as increase the likelihood of normal visual development.
Contact: Maya Eibschitz, M.D., 734-844-2040
Principal Investigator: Maya Eibschitz, M.D., 734-844-2040

Retina Trials

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.

The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study. Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide with Standard Care to Treat Macular Edema: One for Central Retinal Vein Occlusion (CRVO) and One for Branch Retinal Vein Occlusion (BRVO)
This study will compare conventional treatment of macular edema secondary to vein occlusion with varying doses of an intravitreal steroid injection. This study will help determine if steroids are safe in treating macular edema and what dose is most effective. To participate in this 36 month trial, subjects must be 18 years or older and have history of center-involved macular edema secondary to CRVO and BRVO that has been present and untreated for at least 3 months, but not longer than 18 months.
Contact: Julie Gothrop, C.O.A., 734-936-9798
Principal Investigator: Mark W. Johnson, M.D., 734-936-7760
Study Sponsor: National Eye Institute