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INFORMED CONSENT FOR INTRAVITREAL
KENALOGTM (TRIAMCINOLONE) INJECTION (IVKI)
INDICATIONS AND POSSIBLE BENEFITS
You have been diagnosed with an eye condition that causes swelling, inflammation, leakage from
the blood vessels in the eye, and/or the abnormal growth of blood vessels. Triamcinolone
acetonide (KenalogTM) is a steroid which can be injected into the jel y or vitreous portion of the
eye. IVKI reduces the swel ing, leakage, and abnormal blood vessel growth, and may improve
how well you see.
“OFF-LABEL” STATUS INFORMATION
Kenalog,TM is approved to treat the swel ing caused by many medical conditions, but is not
approved for use in the eye. TriesenceTM and TrivarisTM are forms of triamcinolone that are
approved by the Food and Drug Administration (FDA) for certain eye conditions such as
sympathetic ophthalmia, temporal arteritis, uveitis, and when the inflammation caused by other
eye conditions does not improve with steroid eye drops. Retina specialists use triamcinolone in
its various forms to treat many other eye conditions. The use of a medication for an “off-label”
purpose is a legal and necessary part of the practice of medicine. The FDA has confirmed that
once it approves a medication, physicians may use it “off-label” for other purposes if that use wil
benefit their patient. “Off-label use of a medication is appropriate when there is sound medical
evidence for its use. POSSIBLE LIMITATIONS
The goal of treatment with IVKI is to prevent further loss of vision. Although some patients have
regained vision, the medication may not restore vision that has already been lost, and may not
ultimately prevent further loss of vision caused by your disease. ADMINISTRATION
After the pupil is dilated and the eye is numbed with anesthesia, the medication is injected into the
vitreous, the jel y-like substance in the back part of the eye. IVKI is administered into your eye as
You do not have to receive IVKI treatment for your condition, although without treatment, diseases
like yours can lead to further vision loss and blindness, sometimes very quickly. COMPLICATIONS FROM THE MEDICATION AND INJECTION
Your condition may not get better or it may become worse. Any or al of these complications
discussed below may cause you to lose vision or cause blindness. Additional medications or
procedures, including surgery, may be needed to treat these complications. During the fol ow up
visits, you wil be checked for possible side effects and the results wil be discussed with you.
Possible complications and side effects of IVTA include, but are not limited to, retinal detachment,
cataract formation (clouding of the lens of the eye), glaucoma (increased pressure in the eye),
hypotony (reduced pressure in the eye), damage to the retina or cornea (structures of the eye),
and bleeding. There is also the possibility of an eye infection (endophthalmitis). Any of these rare
complications may lead to severe, permanent loss of vision.
Patients receiving IVTA may experience less severe side effects related to the pre-injection
preparation procedure (eyelid speculum, anesthetic drops, dilating drops, antibiotic drops,
povidone-iodine drops and the injection of the anesthetic). These side effects may include eye
pain, subconjunctival hemorrhage (bloodshot eye), vitreous floaters, irregularity or swel ing of the
cornea, inflammation of the eye, and visual disturbances. PATIENT CONSENT:
The above explanation has been read by/to me. The nature of my eye condition has been
explained to me and the proposed treatment has been described. The risks, benefits, alternatives,
and limitations of the treatment have been discussed with me. Al of my questions have been
I understand that KenalogTM was approved by the FDA for injections into muscles, the skin,
and joints, and that it has not been approved for injection in or around the eye to treat eye conditions. Nevertheless, I wish to be treated with KenalogTM, and I am wil ing to accept the potential risks that my physician has discussed with me.
I wil take al prescribed medications exactly as ordered and wil immediately contact my
ophthalmologist if any of the fol owing signs of infection or other complications develop: pain, blurry or decreased vision, sensitivity to light, redness of the eye (compared to immediately after the injection), or discharge from the eye. I have been instructed NOT to rub my eyes or swim for three days after each injection. I wil keep al post-injection appointments or scheduled telephone calls so my doctor can check for complications.
I hereby authorize Dr. Claron D. Al dredge to administer the intravitreal injection of TA as
needed. This consent wil be valid unless I revoke it by refusing an injection or my condition changes to the point that the risks and benefits of this medication for me are significantly different.
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Frequently Asked Questions This document has been put together with the aim of answering the most frequently asked questions of parents with newly diagnosed MTM babies. The responses have been provided by parents who have been through the early stages of this condition - it is not intended to replace medical advice but to augment it and to allow parents to make well informed choice