Triple Therapy for Diffuse Diabetic Macular Edema

NCT01218750 | Unknown DMC

• 1 other identifier: 46/WIM/2008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diffuse Diabetic Macular Edema

Keywords

DDME, ppV, ILM peeling, bevacizumab injection

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Secondary Outcomes (1)

• Presence of vitreomacular traction or epimacular membrane, grade of DR, patients age, HbA1c level, BMI, systemic hypertension

  up to 2 weeks before surgery

Study Arms (1)

edematous tractional epimacular membrane

EXPERIMENTAL

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.

Procedure: Triple therapy for diffuse diabetic macular edema

Interventions

Triple therapy for diffuse diabetic macular edema PROCEDURE

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.

Also known as: Triple Therapy, Avastin (bevacizumab)

edematous tractional epimacular membrane

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine

Warsaw, Szaserów 44, 04-141, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 20572497 RESULT

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Robaszkiewicz Jacek, dr med.

  Department of Ophthalmology Military Institute of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robaszkiewicz Jacek, dr med.

CONTACT

+48604597970; vectra@izet.pl

Chmielewska Katarzyna, lek.med.

CONTACT

+48509142510; kchmielewska@interia.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 11, 2010
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: October 19, 2010

Record last verified: 2010-09

Locations

PL (1)