Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy

Khairallah Moncef

Status and phase: Enrolling; Phase 4

Conditions: Proliferative Diabetic Retinopathy; Vitreous Hemorrhage; Tractional Retinal Detachment

Treatments: Procedure: Peripheral Retinal Cryoapplication; Drug: Bevacizumab Injection [Avastin]

Study type: Interventional

Funder types: Other

Identifiers

NCT05514925

LR18SP09 N01

IORG0009738 N95 (Registry Identifier)

Details and patient eligibility

About

Pars-plana vitrectomy (PPV) is the cornerstone of surgical treatment for eyes with complicated proliferative diabetic retinopathy. Anti-VEGF intravitreal injection before PPV has shown a good effect on surgical outcomes. However, many patients present with co-morbidities that contraindicate the usage of anti-VEGF in the pre-operative period. Thus, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy may be a good alternative. The investigators present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.

Full description

Pars-plana vitrectomy (PPV) is the cornerstone of surgical treatment of complicated proliferative diabetic retinopathy allowing the removal of vitreous opacity and releasing tractions from the retina. Surgical outcomes, however, are variable depending on a large array of pre, per, and post-operative conditions.

The preoperative anti-VEGF intravitreal injection has shown a good effect on surgical outcomes in patients with vitreous hemorrhage or tractional retinal detachment.

However, a great number of patients present with co-morbidities that contraindicate the usage of anti-VEGF in the pre-operative period.

Thus, an alternative to this adjunctive therapy is worth investigating. In another hand, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy had been used in patients with non-clear ocular media with vitreous hemorrhage.

The investigators present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or 2 diabetes mellitus
• Vitreous or retro-hyaloidal hemorrhage and/or tractional retinal detachment threatening or involving the macula
• No or less than 1000 impacts of preoperative retinal photocoagulation and/or iris rubeosis
• Only one eye per participant

Exclusion criteria

• Negative light perception
• Previous vitrectomy
• Contraindication to anti-VEGF therapy or retinal cryoapplication
• Associated rhegmatogenous retinal detachment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Preoperative Anti-VEGF Intravitreal Injection

Active Comparator group

Description:

Three to five days before vitrectomy, each participant received one intravitreal Bevacizumab injection (1.25 mg,0.05 ml).

Treatment:

Drug: Bevacizumab Injection [Avastin]

Peripheral Retinal Cryoapplication

Experimental group

Description:

Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication.

Treatment:

Procedure: Peripheral Retinal Cryoapplication