UnknownPhase 1/2

Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

Brazil50 participantsStarted 2006-10

Plain-language summary

Phase I/II study with intravitreal triamcinolone acetonide microspheres(RETAAC)for treatment of diffuse diabetic macular edema unresponsive to laser photocoagulation. Study hypothesis is that single intravitreal injection of RETAAC is safe and efficient compared to conventional treatment. Fifty patients will participate in this study and will be randomized into treatment and observation groups. Efficacy will be evaluated by best corrected visual acuity and macular thickness measured by optic coherence tomography (OCT) after 12 months of treatment.

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: * Diabetes mellitus (type 1 or 2) * Diabetic macular edema in study eye associated to diabetic retinopathy * Diffuse macular edema defined as macular thickening determined by biomicroscopy and fluorescein angiography. * Best corrected visual acuity between 34 (20/200) and 68 letters (20/50). * Macular thickness greater than 300 mcm on OCT. Exclusion Criteria: * Uncontrolled systemic disease * Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit. * HbA1c levels greater than 10% * Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema. * Presence of epiretinal membrane * Presence of vitreomacular traction in the study eye. * Aphakic or anterior chamber intraocular lens in the study eye. * Neovascularization of disc or elsewhere in the study eye. * History or presence of choroidal neovascularization in the study eye. * Presence of rubeosis irides in the study eye. * Eye opacity that interfere with clinical documentation and photography. * Intra-ocular surgery 90 days before initial visit. * Previous vitrectomy in study eye. * Previous history of intravitreal or periocular corticoid or any other intravitreal drug in study eye. * Scheduled surgery for study eye. * Patients with known allergies to fluorescein, iodo-povidone or any component of study drug.

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

Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.

Timeframe: 12 months

Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment.

Timeframe: 12 months

Safety of intravitreal triamcinolone acetonide after 12 months of treatment.

Timeframe: 12 months

Trial details

NCT IDNCT00407849

SponsorFederal University of São Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-12

View on ClinicalTrials.gov More Diabetic Retinopathy trials

Plain-language summary

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.

What they're measuring

Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.

Timeframe: 12 months

Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment.

Timeframe: 12 months

Safety of intravitreal triamcinolone acetonide after 12 months of treatment.

Timeframe: 12 months