Triple Therapy for Diffuse Diabetic Macular Edema

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01218750
• Date of registration: 06/10/2010
• Primary sponsor: Military Institute of Medicine, Poland
• Public title: Triple Therapy for Diffuse Diabetic Macular Edema TTDDME
• Scientific title: Combined Phako-Vitrectomy With ILM Peeling, Retinal Endophotocoagulation, and Intraoperative Use of Bevacizumab for Diffuse Diabetic Macular Edema
• Date of first enrolment: December 2008
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01218750
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Poland

Contacts

• Name: Kowal Ewelina

• Name: Robaszkiewicz Jacek, dr med.

• Name: Robaszkiewicz Jacek, dr med.
• Affiliation: Department of Ophthalmology Military Institute of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

1. diagnosis of DDME on clinical exam, definite retinal thickening involving the center
of the macula, confirmed by fluorescein angiography, with or without PVD,

2. 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),

3. mean central macular thickness greater than 250 µm on optic coherence tomography
(OCT),

4. presence of vitreomacular traction or a thickened and taut posterior hyaloid or
presence of an epimacular membrane.

Exclusion Criteria:

1. significant macular ischemia defined as enlarged perifoveal capillary loss (>1000 µm)
by fluorescein angiography,

2. the focal macular edema due to focal leakage from microaneurysm,

3. ophthalmic disorders associated with macular edema, such as uveitis, branch or
central retinal vein occlusion and pseudophakic cystoid macular edema,

4. vitreous hemorrhage or tractional retinal detachment secondary to diabetic
retinopathy,

5. 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),

6. history of retinal macular photocoagulation, intravitreal corticosteroids, or other
treatment for DME within 3 months prior to enrollment,

7. history of any intraocular surgery within prior 6 months.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diffuse Diabetic Macular Edema

Intervention(s)

Procedure: Triple therapy for diffuse diabetic macular edema

Primary Outcome(s)

Best-corrected visual acuity (BCVA) and central macular thickness (CMT) [Time Frame: 16 up to 17 weeks after surgery]

Best-corrected visual acuity (BCVA) and central macular thickness (CMT) [Time Frame: 32 up to 33 weeks after surgery]

Best-corrected visual acuity (BCVA) and central macular thickness (CMT) [Time Frame: 48 up to 49 weeks after surgery]

Best-corrected visual acuity (BCVA) and central macular thickness (CMT) [Time Frame: 64 up to 65 weeks after surgery]

Best-corrected visual acuity (BCVA) and central macular thickness (CMT) [Time Frame: up to 1 week before surgery]

Secondary Outcome(s)

Presence of vitreomacular traction or epimacular membrane, grade of DR, patients age, HbA1c level, BMI, systemic hypertension [Time Frame: up to 2 weeks before surgery]

Secondary ID(s)

46/WIM/2008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors