NCT01218750|UnknownDMC
Triple Therapy for Diffuse Diabetic Macular Edema
TTDDME
Combined Phako-Vitrectomy With ILM Peeling, Retinal Endophotocoagulation, and Intraoperative Use of Bevacizumab for Diffuse Diabetic Macular Edema
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TTDDME
Combined Phako-Vitrectomy With ILM Peeling, Retinal Endophotocoagulation, and Intraoperative Use of Bevacizumab for Diffuse Diabetic Macular Edema
Sponsor study identifier
interventional
30
1 country
1
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 6, 2010
Actual (reported)October 11, 2010
Actual (reported)December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
The best corrected visual acuity (BCVA) for ETDRS chart and central macular thickness (CMT) are assessed preoperatively and during the follow-up period. OCT is performed 1 mm and 6 mm diameter topography centered at the patient fixation point. We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.
up to 1 week before surgery
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
The best corrected visual acuity (BCVA) for ETDRS chart, results are converted to log MAR for statistical analysis. The central macular thickness (CMT) are assessed 1 mm diameter topography centered at the patient fixation point for OCT-SLO. We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.
16 up to 17 weeks after surgery
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
A follow-up examination include: The best corrected visual acuity (BCVA) for ETDRS chart, results are converted to log MAR for statistical analysis. The central macular thickness (CMT) are assessed 1 mm diameter topography centered at the patient fixation point for OCT-SLO. We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.
32 up to 33 weeks after surgery
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
A follow-up examination include: The best corrected visual acuity (BCVA) for ETDRS chart, results are converted to log MAR for statistical analysis. The central macular thickness (CMT) are assessed 1 mm diameter topography centered at the patient fixation point for OCT-SLO. We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.
Presence of vitreomacular traction or epimacular membrane, grade of DR, patients age, HbA1c level, BMI, systemic hypertension
up to 2 weeks before surgery
Diabatic maculopathy comes to the edematous or tractional form. It is believed that epiretinal membranes are comprised from glial components. The processes of these cells may invade through the internal limiting membrane of the retina to the vitreous causing the vitreoretinal adhesion and anomalous posterior detachment of vitreous (APVD). In the macula, APVD causes vitreo-macular traction syndrome, which results in diffuse diabetic macular edema. If vitreoschisis is present, a place of dissection is crucial. If break occurs in front of the hyalocytes remaining on the retinal surface, the vitreous layer is thick and easily shrinks concentrically, which results in the formation of epimacular membrane.
Three port pars plana vitrectomy is performed by one surgeon (JR). Induction of PVD is initiated by active suction with the vitrectomy probe over the ONH and continued peripherally. Peeling of the epimacular tissue and ILM is performed by grasping the flap of the ILM with an eckhardts forceps. Trypan Blue is used to stain the ILM. Peripheral laser endophotocoagulation is performed in cases of avascular areas based on FA, active neovascularization, peripheral retinoschisis or retinal breaks. All eyes have a 1,25 mg/0,05 ml bevacizumab injection into vitreous cavity and SF6 gas tamponade at the end of the procedure. Even of absence of cataract formation, a combined procedure is performed because of exactly peripheral vitreous shaving and prevention of cataract formation.
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Military Institute of Medicine
Warsaw, Szaserów 44, 04-141, Poland
Robaszkiewicz J, Chmielewska K, Wierzbowska J, Figurska M, Frontczak-Baniewicz M, Stankiewicz A. [Combined surgical and pharmacological treatment of diabetic maculopathy]. Klin Oczna. 2010;112(1-3):19-23. Polish.
Robaszkiewicz Jacek, dr med.
Department of Ophthalmology Military Institute of Medicine
First Submitted
October 6, 2010
First Posted
October 11, 2010
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Estimated (date passed)48 up to 49 weeks after surgery
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
A follow-up examination include: The best corrected visual acuity (BCVA) for ETDRS chart, results are converted to log MAR for statistical analysis. The central macular thickness (CMT) are assessed 1 mm diameter topography centered at the patient fixation point for OCT-SLO. We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.
64 up to 65 weeks after surgery
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 19, 2010
Record last verified: 2010-09
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Source: ClinicalTrials.gov.
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