Avastin Injection Consent

PATIENT _________________________________________DATE __________________ OD OS
INFORMED CONSENT FOR

TM
AVASTIN (BEVACIZUMAB) INTRAVITREAL INJECTION
INDICATIONS
Age-related macular degeneration (AMD) is the leading cause of blindness in people over 50 years of
age. There are two types of macular degeneration: dry and wet. In the “wet” form of AMD, abnormal
blood vessels grow in the back of the eye. Sometimes these vessels leak blood or fluid that causes blurred
or distorted vision. Without treatment, vision loss may be quick and severe.
There are other eye conditions that cause loss of vision due to abnormal growth of blood vessels in the
back of the eye. These can occur even in young patients, and include, but are not limited to, conditions
such as high myopia (nearsightedness), histoplasmosis, angioid streaks, and eye injury. Sometimes there
is no known reason for the abnormal blood vessels. Without treatment, vision loss may be quick and
severe.
Refractory macular edema, or swelling around the macula, is edema that affects vision but does respond
adequately to the usual treatment methods. It can occur with conditions such as central retinal vein
occlusion and diabetic retinopathy. Without effective treatment, vision loss could progress and become
permanent.
POSSIBLE BENEFITS AND “OFF-LABEL” STATUS

AvastinTM was not initially developed to treat your eye condition. Based upon the results of clinical trials
that demonstrated its safety and effectiveness, AvastinTM was approved by the Food and Drug
Administration (FDA) for the treatment of metastatic colorectal cancer. As a condition of approval, the
manufacturer produced a “label” explaining the indications, risks, and benefits. The label explains that
AvastinTM works by blocking a substance known as vascular endothelial growth factor of VEGF.
Blocking or inhibiting VEGF helps prevent further growth of the blood vessels that the cancer needs to
continue growing.
Once a device or medication is approved by the FDA, physicians may use it “off-label” for other purposes
if they are well-informed about the product, base its use on firm scientific method and sound medical
evidence, and maintain records of its use and effects. Ophthalmologists are using AvastinTM “off-label” to
treat AMD and similar conditions since research indicates that VEGF is one of the causes for the growth
of the abnormal blood vessels that cause these conditions. Some patients treated with AvastinTM had less
fluid and more normal-appearing maculas, and their vision improved. AvastinTM is also used, therefore, to
treat macular edema, or swelling of the macula. Recently, a medication similar in function and designed
for intravitreal administration was approved by the FDA for the treatment of AMD.
POSSIBLE LIMITATIONS AND ADMINISTRATIONS

The goal of treatment is to prevent 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 the disease. After the pupil is dilated and the eye is numbed with anesthesia, the
medication is injected into the vitreous or jelly-like substance in the back chamber of the eye. AvastinTM
is administered by an injection into your eye as needed at regular intervals (about every four to six
weeks); your ophthalmologist will tell you how often you will receive the injection, and for how long.
ALTERNATIVES
You do not have to receive treatment for your condition, although without treatment, these diseases can
lead to further vision loss and blindness, sometimes very quickly. Other forms of treatment are available.
At present, there are three FDA-approved treatments for neovascular age-related macular degeneration.
The first two are photodynamic therapy with a drug called VisudyneTM and injection into the eye of a dug
called MacugenTM. Although both of these treatments have been proved to slow down the rate of visual
loss, most people do not get back better vision. The third medication, LucentisTM is similar to AvastinTM.
Your doctor will discuss with you the benefits and risks associated with these other choices of treatment.
In addition to the FDA-approved medications, some ophthalmologists use intravitreal Triamcinolone
Acetonide –a long-acting cortisone-like drug- “off-label” to treat eye conditions like yours.
COMPLICATIONS FROM THE MEDICATION AND INJECTION

Complications when AvastinTM is given to patients with cancer
When AvastinTM is given to patients with metastatic colorectal cancer, some patients experienced serious
and sometimes life-threatening complications, such as gastrointestinal perforations of wound healing
complications, hemorrhage, arterial thromboembolic events (such as stroke or heart attack), hypertension,
proteinuria, and congestive heart failure.
Patients who experienced these complications not only had metastatic colon cancer, but were also given
400 times the dose you will be given, at more frequent intervals, and in a way (through and intravenous
infusion) that spread the drug throughout their bodies.
Risk when AvastinTM is given to treat patients with eye conditions

Ophthalmologists believe that the risk of these complications for patients with eye conditions is low.
Patients receiving AvastinTM for eye conditions are healthier than the cancer patients, and receive a
significantly small dose, delivered only to the cavity of their eye. While there are no FDA-approved
studies about the use of AvastinTM in the eye that prove it is safe and effective, LucentisTM, a similar drug,
was recently approved for AMD. One study of patients who received AvastinTM through an intravenous
infusion reported only a mild elevation in blood pressure. Another study of patients treated like you will
be with intravitreal AvastinTM (that is, AvastinTM injected into the eye) did not have these elevations or
other serious problems seen in the patients with cancer.
However, the benefits and risks of intravitreal AvastinTM for eye conditions are not fully known. In
addition, whenever a medication is used in a large number of patients, a small number of coincidental life-
threatening problems may occur that have no relationship to the treatment. For example, patients with
diabetes are already at increased risk for heart attack and strokes. If one of these patients being treated
with AvastinTM suffers a heart attack or stroke, it may be caused by the diabetes and not the AvastinTM
treatment.
Known risks of intravitreal eye injections

Your condition may not get better or may become worse. Any or all of these complications may
cause decreased vision and/or have a possibility of causing blindness. Additional procedures may be
needed to treat these complications. During the follow up visits or phone calls, you will be checked for
possible side effects and the results will be discussed with you.
Possible complications and side effects of the procedure and administration of AvastinTM 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).
You may receive eye drops with instructions on when to use them to reduce the possibility of this
occurring. Any of these rare complications may lead to severe, permanent loss of vision.
Patients receiving an injection of AvastinTM may experience less severe side effects related to the pre-
injection preparation procedure (eyelid speculum, anesthetic drops, dilating drops, antibiotic drops, and
povidone-iodine drops). These side effects may include eye pain, subconjunctival hemorrhage (bloodshot
eye), vitreous floaters, irregularity or swelling of the cornea, inflammation of the eye, and visual
disturbances.
PATIENT RESPONSIBILITIES
I will immediately contact my ophthalmologist if any of the following 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 will keep all post-injection appointments or scheduled
telephone calls so my doctor can check for complications.
____________________ Patient initials
Although the likelihood of serious complications affecting other organs of my body is low, I will
immediately contact my primary care physician or go to the emergency room if I experience abdominal
pain associated with constipation and vomiting, abnormal bleeding, chest pain, severe headache, slurred
speech, or weakness on one side of the body. As soon as possible, I will also notify my ophthalmologist
of these problems.
I will inform my ophthalmologist if I need to have any surgery, and I will inform any other surgeon,
including dentists, that I am on a medication that needs to be stopped before I can have surgery.
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. All my questions have been answered.
I understand that AvastinTM was approved by the FDA for the treatment of metastatic colorectal cancer,
and has not been approved for the treatment of eye conditions. Nevertheless, I wish to be treated with
AvastinTM, and I am willing to accept the potential risks that my physician has discussed with me.
I hereby authorize Dr. __________________ to administer the intravitreal injection of AvastinTM in my

____________ (state “right” or “left”) eye at regular intervals as needed. This consent will be valid until I
revoke it or my condition changes to the point that the risks and benefits of this medication for me are
significantly different.
____________________________________ ________________________
Patient’s Signature Date
____________________________________ ________________________
Witness’s Signature Date
____________________________________ ________________________
Physician’s Signature Date

Avastin Injection Consent

Uploaded by

Copyright:

Available Formats

Avastin Injection Consent

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Avastin Injection Consent

Uploaded by

Copyright:

Available Formats

PATIENT _______________________DATE OD OS

INFORMED CONSENT FOR

POSSIBLE BENEFITS AND “OFF-LABEL” STATUS

POSSIBLE LIMITATIONS AND ADMINISTRATIONS

COMPLICATIONS FROM THE MEDICATION AND INJECTION

Risk when AvastinTM is given to treat patients with eye conditions

Known risks of intravitreal eye injections

____________________ Patient initials

____________________ Patient initials

____________________ Patient initials

____________________ Patient initials

I hereby authorize Dr. __________________ to administer the intravitreal injection of AvastinTM in my

You might also like