Clinical trial NCT05514925: Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy
Official title: Peripheral Retinal Cryoapplication Versus Anti-VEGF Intravitreal Injection Before Vitrectomy for Complicated Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Proliferative Diabetic Retinopathy
Vitreous Hemorrhage
Tractional Retinal Detachment
Keywords: Retinal cryoapplication
Anti-VEGF
Vitrectomy
Lead sponsor: University Hospital Fattouma Bourguiba
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total surgical time
timeFrame: at the end of the vitrectomy
measure: Intraoperative bleeding
timeFrame: at the end of the vitrectomy
Secondary outcomes:
measure: Postoperative bleeding
timeFrame: one month after the vitrectomy
measure: Visual acuity
timeFrame: one month after the vitrectomy
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital - Ophthalmology Department
Study officials:
affiliation: Fattouma Bourguiba University Hospital
name: Imen Ksiaa, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang ZH, Liu HY, Hernandez-Da Mota SE, Romano MR, Falavarjani KG, Ahmadieh H, Xu X, Liu K. Vitrectomy with or without preoperative intravitreal bevacizumab for proliferative diabetic retinopathy: a meta-analysis of randomized controlled trials. Am J Ophthalmol. 2013 Jul;156(1):106-115.e2. doi: 10.1016/j.ajo.2013.02.008.
citation: Arevalo JF, Lasave AF, Kozak I, Al Rashaed S, Al Kahtani E, Maia M, Farah ME, Cutolo C, Brito M, Osorio C, Navarro P, Wu L, Berrocal MH, Morales-Canton V, Serrano MA, Graue-Wiechers F, Sabrosa NA, Alezzandrini AA, Gallego-Pinazo R; Pan-American Collaborative Retina Study (PACORES) Group. Preoperative Bevacizumab for Tractional Retinal Detachment in Proliferative Diabetic Retinopathy: A Prospective Randomized Clinical Trial. Am J Ophthalmol. 2019 Nov;207:279-287. doi: 10.1016/j.ajo.2019.05.007. Epub 2019 May 13.
citation: Lim AS, Ang BC. Cryoapplication in diabetic retinopathy. Int Ophthalmol. 1986 May;9(2-3):139-41. doi: 10.1007/BF00159842.