Triple Therapy for Diffuse Diabetic Macular Edema

NCT ID: NCT01218750

Last Updated: 2010-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-12-31

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.

Detailed Description

The pathogenesis of the diabetic macular edema is multiple. Therefore treatment of this disease should be combined too. VEGF is involved in pathogenesis of diabetic macular edema and recently anti-VEGF agents such as bevacizumab have been shown to be beneficial in the treatment of this retinal disorder. However, endogenous VEGF is required for visual function. Growing body evidence indicates that VEGF acts also on nonvascular cells, it plays survival role on Muller cells and photoreceptors. Therefore anti-VEGF therapies should be administered with caution and not persistent. Photocoagulation in nonperfused areas eliminate increased production of VEGF, proliferation of RPE and increased production of PEDF in surrounded impact laser area. Vitrectomy with ILM peeling reliefs traction on the macula, improve oxygenation of the macula leading to decreased vascular permeability with subsequent resolution or decrease in DME. Removed ILM contains a part of the Müller cell endfeet and the horizontal gliosis. It is likely that the proliferation of GFAP-stained gliofibrils, observed in microdamaged Müller cells, preserves the blood-retinal barrier, reinforces architectural cohesion, and opposes the installation of the edema. Therefore, we made hypothesis that combined triple therapy was effective for decreasing macular thickness and improvement of vision for eyes with diffuse diabetic macular edema.

It is important for the surgeon to determine the factors that might influence surgical outcome so that patients are chosen for the procedure that they can get benefit from. Therefore, we evaluated the possible preoperative and intraoperative factors that might influence surgical outcomes

Conditions

Diffuse Diabetic Macular Edema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

edematous tractional epimacular membrane

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.

Group Type: EXPERIMENTAL

Triple therapy for diffuse diabetic macular edema

Intervention Type: 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.

Interventions

Triple therapy for diffuse diabetic macular edema

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.

Intervention Type: PROCEDURE

Other Intervention Names

Triple Therapy; Avastin (bevacizumab)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Military Institute od Medicine National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Military Instiute of Medicine, Warsaw

Principal Investigators

Robaszkiewicz Jacek, dr med.

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology Military Institute of Medicine

Locations

Military Institute of Medicine

Warsaw, Szaserów 44, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Robaszkiewicz Jacek, dr med.

Role: CONTACT

vectra@izet.pl

+48604597970

Chmielewska Katarzyna, lek.med.

Role: CONTACT

kchmielewska@interia.pl

+48509142510

Facility Contacts

Kowal Ewelina

Role: primary

ekowal@wim.mil.pl

(+48) 22 665 707 584

References

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.

Reference Type: RESULT

PMID: 20572497 (View on PubMed)

Other Identifiers

46/WIM/2008

Identifier Type: -

Identifier Source: org_study_id