Macugen to Prevent Worsening of Macular Edema Following Cataract Surgery in Diabetics (NCT00346983) | Clinical Trial Compass
TerminatedPhase 1/2
Macugen to Prevent Worsening of Macular Edema Following Cataract Surgery in Diabetics
Stopped: Difficulty enrolling eligible subjects
United States4 participantsStarted 2006-06
Plain-language summary
This research is being conducted to look at the effects of an intraocular drug (pegaptanib, also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that often occurs following cataract surgery in patients with diabetic eye disease. Swelling in the retina can lead to blurry vision, and Macugen may reduce this swelling. Eyedrops that decrease inflammation also may help to stop some of the swelling. We are testing this drug (pegaptanib) to see if it can decrease swelling in the retina and improve vision in patients with diabetes who are having cataract surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (ages 18 years or older) with diabetes mellitus
* Best corrected visual acuity worse than 20/40 but no worse than 20/800 in the study eye
* Best corrected visual acuity better than or equal to 20/800 in the fellow eye
* DME in the study eye (eye scheduled to undergo cataract surgery) as documented on OCT as a center point thickness of at least 250 microns no more than 3 weeks prior to cataract surgery
* No prior laser photocoagulation in the study eye for at least 4 months prior to cataract surgery
* Women of child-bearing potential who are interested in participating in this study will use two effective forms of contraception prior to initiation of pegaptanib and then throughout the remainder of the study. For women of childbearing potential, results from a urine pregnancy test will be obtained prior to each injection with pegaptanib. Urine samples will be disposed of after the test is performed.
Exclusion Criteria:
* History of intravitreal steroid (triamcinolone) injection into the study eye within 4 months prior to cataract surgery
* Macular edema due to non-diabetic etiologies such as vein occlusion
* Retinal diseases that preclude evaluation of the macula for edema (e.g., macular hole)
* Media opacity will not be an exclusion criterion provided that the investigator can assess the presence or absence of DME on OCT
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects avoiding 15 letters (3 lines) of best-corrected distance visual acuity loss at 18 weeks after cataract surgery. Distribution of visual acuity changes at 18 weeks after cataract surgery
Timeframe: 1 to 18 weeks post-cataract surgery
2
Distribution of absolute levels of distance visual acuity at 18 weeks after cataract surgery
Timeframe: 1 to 18 weeks post-cataract surgery
3
Analysis of time to 15 letter improvement of best-corrected distance visual acuity through 18 weeks after cataract surgery using a 2-state stochastic model to account for events and recoveries from events