The purpose of this study is to evaluate the safety end efficacy of combined phakoemulsification and vitrectomy with retinal endophotocoagulation and intraoperative use of bevacizumab in patients with diffuse diabetic macular edema (DDME), to determine the possible preoperative and intraoperative factors that might influence surgical outcomes.
Who can participate
Age range
18 Years – 80 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
. diagnosis of DDME on clinical exam, definite retinal thickening involving the center of the macula, confirmed by fluorescein angiography, with or without PVD,
. BCVA of 0,3 or worse in log MAR units (\<=70 ETDRS letter) and 1,5 or better in log MAR units (\>=10 ETRDS letter),
. mean central macular thickness greater than 250 μm on optic coherence tomography (OCT),
. presence of vitreomacular traction or a thickened and taut posterior hyaloid or presence of an epimacular membrane.
Exclusion criteria
. significant macular ischemia defined as enlarged perifoveal capillary loss (\>1000 µm) by fluorescein angiography,
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
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Timeframe: up to 1 week before surgery
2
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Timeframe: 16 up to 17 weeks after surgery
3
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Timeframe: 32 up to 33 weeks after surgery
4
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Timeframe: 48 up to 49 weeks after surgery
5
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Timeframe: 64 up to 65 weeks after surgery
Trial details
NCT IDNCT01218750
SponsorMilitary Institute od Medicine National Research Institute
. the focal macular edema due to focal leakage from microaneurysm,
. ophthalmic disorders associated with macular edema, such as uveitis, branch or central retinal vein occlusion and pseudophakic cystoid macular edema,
. vitreous hemorrhage or tractional retinal detachment secondary to diabetic retinopathy,
. an ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary abnormalities, dense subfoveal hard exudates),
. history of retinal macular photocoagulation, intravitreal corticosteroids, or other treatment for DME within 3 months prior to enrollment,
. history of any intraocular surgery within prior 6 months.