Clinical Studies
Current Clinical Studies
We have successfully completed single center and multi-center clinical studies evaluating diagnostic tests, pharmaceuticals, biologics, surgical procedures, and medical devices for acute and chronic pain, congestive heart failure and other cardiac diseases, osteoarthritis and other orthopedic diseases, cancer, seizure disorders, endocrine diseases, ophthalmologic conditions, and chronic skin diseases. You can explore our current clinical studies below.
This is a USDA regulated scientific study. Enrollment is limited to dogs with osteosarcoma, hemangiosarcoma and transitional cell carcinoma. The vaccine is currently provided at no charge to the owner. As this is not a fully funded study, all costs associated with office visits, diagnostics and vaccine administration are the responsibility of the owner. If the vaccine receives approval, it will no longer be provided at no cost. MedVet Chicago, MedVet Cincinnati, MedVet Cleveland, MedVet Pittsburgh, and MedVet Salt Lake City are currently enrolling patients.
In order to ensure all patients meet the enrollment criteria of having an expected prognosis that is greater than three months, MedVet hospitals are currently limiting enrollment to patients who are receiving appropriate standard of care therapies which may include surgery, chemotherapy, and/or radiation therapy depending on the tumor type. Patients being screened for enrollment with the intent to use the vaccine as a single agent treatment will not be considered.
- Histologically (biopsy) confirmed diagnosis of osteosarcoma, hemangiosarcoma, or transitional cell carcinoma. An exception may be made if the dog has a long bone (limb) lesion consistent with osteosarcoma and the owner has elected not to pursue amputation.
- If amputation is planned, the first dose of vaccine can be administered following the amputation.
- Anticipated survival of greater than 3 months as determined by the evaluating oncologist.
- While dogs with metastases may be enrolled in the study, this will be based on the extent/volume of disease and prognosis.
- Dogs cannot be enrolled if they are receiving other immunotherapies or alternative therapies or are enrolled in another clinical study. Traditional chemotherapy and radiation therapy are allowed.
- Chest x-rays, CBC, biochemical profile, and urinalysis at baseline prior to vaccine administration. Testing completed within seven days will likely be acceptable.
- Chest x-rays must be repeated at 3, 6, and 9 months
- A blood sample will be collected at each visit (baseline, day 21, day 40-50, 3 months, 6 months, 9 months) for research purposes.
- Strict adherence to the vaccine administration guidelines is required. A booster vaccine must be given 21 days following the initial dose. It is allowable to administer the booster 1 day early or up to 7 days late if necessary due to appointment availability or if the administration day falls on a weekend or holiday.
- Dogs must be ≥ 6 months old
- Diagnosis of KCS based on history and/or ophthalmic examination
- Schirmer Tear Test (STT) of ≥ 2 mm/minute and ≤ 10 mm/minute in one or both eyes
- Dogs must have a score of 2 or above on at least 2 of the 3 conjunctival signs associated with KCS
- Owner must be willing to comply with the protocol restrictions and the visit schedule
- Dogs with chronic medical conditions (for example, endocrinopathies, cardiovascular conditions, atopy, etc.) are permitted, but such conditions must be stabilized prior to enrolling the dog in the study and these animals must not be receiving prohibited concomitant medications
- Dogs with non-KCS ophthalmic conditions that require one or more ophthalmic medications (e.g., glaucoma)
- Dog diagnosed with KCS at < 6 months of age in order to exclude dogs that may have congenital alacrima
- Suspected neurogenic KCS
- History of removal of the third eyelid gland in the affected eye(s)
- KCS associated with a diagnosis of canine distemper
- History of parotid duct transposition in the affected eye(s)
- Punctal plugs in the affected eye(s)
- Non-healed corneal ulcers
- History of local radiation therapy in the ocular region
- Other exclusion criteria not listed above will be discussed with you, include certain prohibited concomitant medication
Your dog will be screened to confirm that it fulfills the inclusion/exclusion criteria for this study. During screening, procedures include obtaining medical history, physical examination, blood and urine collection, obtaining a body weight, and an eye examination will be performed. This is a randomized, masked, negatively-controlled trial. Your dog will be randomly assigned to receive the investigational drug or a negative control product (sterile buffered saline). Neither you nor your veterinarian will be aware of whether your pet is assigned to receive the investigational drug or negative control product. Patients will be randomly assigned based on order of eligibility for enrollment to one of the two treatment groups in a 2:1 ratio of investigational drug to negative control product. If your dog is enrolled in the study, you, the owner/undersigned, will be asked to administer treatments to your dog pursuant to Sponsor’s instructions, which will be provided by your veterinarian.
Your dog will receive treatment under this study, including all tests, procedures, and medications, at no cost to you. If your dog has an allergic reaction or is injured as a result of participating in the study, the Sponsor will work with your veterinarian to cover reasonable expenses related to treatment of such reaction or injury. There are no additional expenses for participating in this study. If your pet is excluded or removed from the study, but requires continued care for eye disease, future examinations and procedures will NOT be covered by the research study. An estimate of costs for which you will be responsible will be prepared for you at the time of admission.
If you are interested in the study and would like to learn more, please reach out to Dr. Terah Webb.
MedVet Silicon Valley is currently enrolling dogs with various cancers in a funded clinical study for veterinary oncology. This multi-institutional, double-blind, randomized, placebo-controlled clinical study evaluating dose and efficacy of a transdermal formulation of a commonly used anti-nausea drug for moderatelyemetogenic chemotherapy.
Dogs over 6 months of age and weighing at least 5 kg diagnosed with neoplasia for which doxorubicin chemotherapy would be indicated. Examples of cancers that are treated with doxorubicin include (but are not limited to) the following:
- lymphoblastic lymphoma
- acute lymphoblastic leukemia
- acute myeloid leukemia
- hemangiosarcoma
- mammary carcinoma
- prostate carcinoma
- thyroid carcinoma
- refractory osteosarcoma
- high-grade soft tissue sarcoma
- nephroblastoma
There will be an initial work-up to determine eligibility. X-rays and/or ultrasound may be recommended. Once study eligibility has been determined and enrollment documents have been signed, a date for doxorubicin administration and study start date is scheduled (Day 1). A topical preparation must be applied to the pet at designated times throughout the study week and a log of patient appetite and gastrointestinal signs must be kept. The study end date is Day 8 +/-2 days.
It is important to note that this is a placebo-controlled trial and there is a 33% chance that a pet will receive a placebo anti-emetic trans-dermal preparation. Clients can withdraw their pet from the study at any time.
This is a funded study so the cost of one dose of doxorubicin chemotherapy will be covered, along with study-related blood tests, study-related medication, and hospital visits. Once enrolled and on study medication, if a dog has any complications related to study treatment that require medical intervention, all medically relevant costs necessary to treat that complication will be covered by the study. Additionally, if their dog completes the study and the client completes all study documentation, each client will receive $200 compensation provided by the study sponsor for their participation.
To learn more about the clinical study, contact MedVet Silicon Valley’s oncology team at 408.649.7070 to consult with Jennifer A. Pierro, DVM, MS, PhD, Diplomate, ACVIM (Oncology).
For other questions, e-mail clinicalstudies@medvet.com.
Contact Us
If you have a pet that you believe may qualify for a clinical study, please contact your family veterinarian. We will work with them to determine if your pet is eligible and could benefit from participation in the study. If you are a veterinarian with a patient that you believe could benefit from a clinical study, please contact us.
MedVet Clinical Studies
Edna Moore, Clinical Studies Supervisor
Frequently Asked Questions
The purpose of a clinical study can vary. For example, the goal may be to determine the effectiveness of a new medication or combinations of medications. Clinical studies can also be used to determine how new procedures can improve quality of life or shorten recovery time for surgical patients. The results from large, multi-center clinical studies are used by both the Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) in the approval process for new drugs and biologicals (vaccines, therapeutic antibodies) for companion animals. Clinical studies used in the approval process are conducted according to the Good Clinical Practice (GCP) recommendations, a set of international guidelines that ensure the highest standards.
Participation in a clinical study is strictly voluntary and requires the pet owner’s written permission. Not every pet qualifies for participation in a clinical study. Communication between our doctors and your family veterinarian is maintained to determine what is best for your pet.
Participating in a clinical study can be rewarding for you and your pet, and you play an important part in helping your own pet as well as future pets. Many medical and surgical treatments are available today because of the participation of pets in clinical studies.
MedVet’s Clinical Studies Center leads collaborative initiatives with our veterinary specialists and veterinarians worldwide. We complete clinical studies by working in partnership with a wide array of investigators, from university faculty members to biotech and pharmaceutical sponsors. The outcome of these important studies benefits our entire veterinary community by putting safer, more effective treatments into the hands of veterinarians here and around the world in support of better patient outcomes.
Clinical studies are well designed to provide the best opportunity to play an active role in your pet’s health care and gain access to new treatments before they are widely available. Your pet will receive expert medical care and close monitoring. Patients enrolled into a clinical study may receive professional services, diagnostic testing, or medical treatments and medications at reduced or no cost, depending on the study.
As with any medical treatment or procedure, clinical studies are not completely risk-free and may require extra time on your part. There may be side effects of the treatment being studied, or the new treatment may not be as effective as hoped. However, treatments used in clinical studies have been rigorously evaluated before advancing to the point of clinical evaluation. Also, clinical study patients are monitored very closely to minimize the chance of any negative effects and ensure participating in the study is the best option for your pet’s ongoing health care.
If your pet has a condition or disease we are currently studying, ask your veterinarian to contact the primary study veterinarian. Working with your veterinarian, the study veterinarian can determine if your pet is a potential candidate. Then, you would meet with the clinical investigative team at MedVet to discuss the study details. You will sign an “informed owner’s consent” document if you elect to have your pet participate. There may also be some screening diagnostics to complete before your pet becomes enrolled. For example, a patient with kidney disease might not be eligible for study, so a blood test would be part of the screening process.
Yes. You have the right to withdraw from a clinical study at any time for any reason.
MedVet’s Clinical Studies Center has worked with a variety of sponsors, from professional to private foundations, to facilitate completion of high-quality clinical studies in client-owned dogs and cats. We can assist you in your development efforts, from pilot investigations through multicenter GCP pivotal efficacy studies. We’re both flexible and creative and foster good working relationships with a goal of ensuring studies are completed in a timely fashion and in compliance with all standards of current Good Clinical Practice (GCP/VICH GL9) guidelines.
Dr. Jon Fletcher, Director of Post-Graduate Medical Education & Clinical Studies, and Edna Moore, Clinical Studies Supervisor, have extensive experience managing and internally monitoring GCP studies. They work with the Clinical Investigative Teams located throughout our organization to ensure all aspects of a study run seamlessly from start-up, patient recruitment, data collection, site monitor and regulatory agency visits, to study close-out processes.
Our strength lies in our ability to recruit many qualified patients in a short period. With an integrated system of more than 35 specialty and emergency hospitals, we have a large and varied caseload of more than 500,000 patients annually. We are also fortunate to have a referral network of more than 7,500 veterinarians who value the role clinical studies play in helping their current and future patients.
Past Clinical Studies
The following trials are no longer accepting new patients:
- Canine Atopic Dermatitis
- Dogs with Protein Losing Enteropathy
- Dogs with Dry Eye
- Dogs with Osteosarcoma
- Large Dogs Requiring Ruptured Cranial Cruciate
- Ligament Repair
- Cats with Diabetes Mellitus
- Small Dogs Requiring Ruptured cranial Cruciate Ligament Repair
- Dogs with Pruritus
- Dogs with Osteoarthritis
- Large Dogs Requiring Ruptured Cranial Cruciate Ligament Repair
- Dogs with Congestive Heart Failure (4 completed studies)
- Dogs with T-cell Lymphoma
- Dogs with Congestive Heart Failure (multi-site study)
- Dogs with Mast Cell Tumors
- Dogs with Diabetes Mellitus (2 completed studies)
- Lymphoma Study in Dogs
- Dogs with Hip Dysplasia
- Dogs Requiring Cranial Cruciate or Luxating Patella Repair Surgery (post-operative pain study)
- Dogs with Ruptured Cranial Cruciate Ligaments
- Dogs with Melanoma, Osteosarcoma, Soft Tissue Sarcoma, and Squamous Cell Carcinoma
- Cats with Congestive Heart Failure
- Dogs with Nasal Carcinoma
- Cats with Oral Squamous Cell Carcinoma
- Dogs with Atopic Disease
- Dogs with Epilepsy
- Dogs with Lymphoma
- Dogs with Glioma
- Dogs With Lens Change
- Dogs in Need of an Amputation
- Canine Diabetes Mellitus
- Cats with Chronic Gingivostomatitis (Stomatitis)