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Click here for information on our
clinical trials
Eyetech
recently completed enrollment for it’s Phase II/III randomized,
double-masked, controlled, multi-center comparative trial, to establish
the safety and efficacy of intravitreal injections of Macugen™ (pegaptanib sodium) in patients with exudative (wet) age-related macular degeneration (AMD).
The purpose of the clinical trial is to determine if Macugen™ (pegaptanib sodium) alone
or combined with Photodynamic Therapy (PDT) in patients with AMD
will result in stabilized and/or better vision. Macular degeneration
affects the central part of the retina in the back of the eye. The
trials involve injection of Macugen™ (pegaptanib sodium) into the vitreous, a jelly-like
fluid that fills the inside of the eye.
Eyetech
recently began enrollment for it’s diabetic macular edema (DME)
trial. Information about this
and any other studies will be posted on this site.
The following information serves to answer some of the most frequently
asked questions by study participants.Eyetech Pharmaceuticals encourages
you to use this information as a resource in combination to the
advice from your ophthalmologist.
What
is Macugen™ (pegaptanib sodium)?
Macugen™ (pegaptanib sodium) is a novel anti-VEGF agent. VEGF - pronounced "Vej-F" - stands for Vascular Endothelial Growth Factor. In the pre-clinical models VEGF stimulates blood vessel growth and causes new, abnormal
blood vessels to grow in the macula. These vessels are fragile and
can leak fluid and blood. Vessel leakage causes distortion of objects,
decreases visual acuity and can lead to scarring with irreversible
central vision loss. As an anti-VEGF agent, injecting Macugen™ (pegaptanib sodium) into
the vitreous may stop abnormal blood vessel growth, leakage, and
eventual scarring.
Will
the procedure cause pain? What are the risks?
The study drug and the procedures in this
study have risks and discomforts associated with them. Macugen™ (pegaptanib sodium) is
an experimental drug that may have side effects that are unknown.
Before a physician administers the injection of Macugen™ (pegaptanib sodium) the patient
will receive a topical numbing drop that may sting slightly and
then a pre-injection of a local anesthetic that totally numbs the
eye. The entire process from initial drop through injection of Macugen™ (pegaptanib sodium)
takes under five minutes. As the specialist administers the medication
(equal to about two drops), one may experience some pressure in
the eye, soreness, itching or blurring of vision. Possible side
effects of the procedure and the administration of drug may include
cataract formation, glaucoma, damage to the retina or cornea, bleeding
and the possibility of an eye infection. Patients will receive eye
drops to reduce the possibility of infection. Bear in mind that
your physician's expertise is the eye and he or she is skilled at
performing procedures on this very complex, efficient, and surprisingly
tough part of the body. Ophthalmologists routinely deliver injections
into the eye for other conditions, including infections and inflammations,
and for varied sight-preserving procedures.
Why
an injection? Why not drops?
One is familiar with the use of drops administered in the front of the eye for conditions including glaucoma, infections, or allergies. However, eye drops cannot reach the exact location in the macula in the back of the eye where the new blood vessels are growing.
By injecting this medication with a very small, fine about a half inch long needle into the vitreous, the retinal specialist is delivering Macugen™ (pegaptanib sodium) directly to the root of the condition, where it is absorbed into the affected tissue.
How
many other patients are participating in these trials?
There are about 1200 patients at over 100 centers worldwide specializing in retinal disease. Retinal specialists at the leading universities and eye hospitals participate in this clinical trial as either investigators or as part of a scientific advisory team for Eyetech Pharmaceuticals. Early trials with a limited
number of patients receiving this treatment have been completed.
What
is my time commitment?
You will visit your participating retinal
specialist on an outpatient basis for examination and treatment
once every six weeks for two years. Your comprehensive care during
these trials will include a routine call from a clinical coordinator
three days after each injection to confirm your comfort and well-being.
If it is convenient, you will return for a check-up to the retinal
specialist seven days after initial injection or you can see your
own ophthalmologist. There are no other post-injection requirements
although you are still advised to protect your eyes and modify your
activities according to the severity of your disease, other treatments
you are receiving, and your specialist's stated instructions.
Do
I need to call the specialist between treatments?
The third-day and seventh-day follow-ups should
cover your concerns. Preliminary trials show that the majority of
patients carried on with their everyday activities between injections.
However, if for any reason you are experiencing symptoms that you
feel are out of the ordinary, please call your doctor or clinical
coordinator.
Will
I complete the trial with improved vision?
Your condition may or may not improve. Clinical
trials are intended to answer questions about safety and efficacy
so there can never be any guarantees. In this trial there is approximately
a one in four chance you will not receive Macugen™ (pegaptanib sodium), so for this reason
alone there can be no guarantees. The preliminary results of trials
with Macugen™ (pegaptanib sodium) conducted by retinal specialists on a small number of
patients, support undertaking this larger, multi-center trial. However,
it is important to understand that the main purpose of this trial
is to prove that the results seen in a few patients can be duplicated
consistently in large numbers of patients proving that the outcome
is attributable to therapy with Macugen™ (pegaptanib sodium).
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