Funktionelle Ergebnisse der intravitrealen Injektion von Triamcinolonacetonid im Vergleich zur konventionellen Lasertherapie bei diabetischem Makulaödem. - DME-TA

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005197-23-DE

Enrollment

Registered

2006-05-17

Start date

2005-10-06

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with diffuse macular edema due to diabetic retinopathy and decrease in visual acuity.

Interventions

Trade Name: Triam-Hexal 40 (Triqmcinolon-acetonid) Product Name: Triam-Hexal 40 Product Code: TA Pharmaceutical Form: Solution for injection INN or Proposed INN: Triamcinolon-acetonide Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? patients with diabetes mellitus II ? signs of diffuse macular edema in both eyes ? indication for (re-)GRID laser-coagulation in both eyes ? best corrected visual acuity of >=0,1 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? macular illness other than diabetic maculopathy ? previous operation in the macular region of the study eye ? previous chorioretinitis or acute infection of the eye (also conjunctivitis) ? glaucoma or known steroid responder ? immunosuppression ? pregnancy/lactation period ? significant opacities, which preclude a clear view of the macular region in the study eye ? other sever illness, which, in the opinion of the study doctor, precludes participation in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparision between efficacy of intravitreal triamcinolone-acetonide in one eye and laser treatment in the other eye in patients with diffuse diabetic macular edema, as measured by change in visual acuity (ETDRS criteria) and retinal sensitivity one year after start of therapy. ;Secondary Objective: Comparision between efficacy of intravitreal triamcinolone-acetonide in one eye and laser treatment in the other eye in patients with diffuse diabetic macular edema, as measured by retinal thickness in the macula by optical coherence tomography and avoidance of loss of 3 or more ETDRS lines one year after start of the therapy.;Primary end point(s): ? change in visual acuity 1 year after start of therapy ? change in retinal sensitivity 1 year after start of therapy	—

Measure

Time frame

Main Objective: Comparision between efficacy of intravitreal triamcinolone-acetonide in one eye and laser treatment in the other eye in patients with diffuse diabetic macular edema, as measured by change in visual acuity (ETDRS criteria) and retinal sensitivity one year after start of therapy. ;Secondary Objective: Comparision between efficacy of intravitreal triamcinolone-acetonide in one eye and laser treatment in the other eye in patients with diffuse diabetic macular edema, as measured by retinal thickness in the macula by optical coherence tomography and avoidance of loss of 3 or more ETDRS lines one year after start of the therapy.;Primary end point(s): ? change in visual acuity 1 year after start of therapy ? change in retinal sensitivity 1 year after start of therapy

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026