Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

Peripheral Retinal Cryoapplication Versus Anti-VEGF Intravitreal Injection Before Vitrectomy for Complicated Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05514925
• Other study ID #: LR18SP09 N01
• Secondary ID: IORG0009738 N95
• Status: Recruiting
• Phase: Phase 4
• Start date: November 21, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: University Hospital Fattouma Bourguiba
• Contact: Imen Ksiaa, Assoc. Prof.
• Phone: +21694994234
• Email: khay.imen[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Hemorrhage
• Proliferative Diabetic Retinopathy
• Retinal Detachment
• Retinal Diseases
• Tractional Retinal Detachment
• Vitreous Hemorrhage

Intervention

Drug:
• Bevacizumab Injection [Avastin]
Intravitreal injection of bevacizumab (1.25 mg, 0.05 ml) in the inferior temporal quadrant of the eye, 4 mm behind the limbus in phakic eyes, and 3.5 mm in pseudophakic eyes.

Procedure:
• Peripheral Retinal Cryoapplication
In the operating room under peribulbar anesthesia, four focal conjunctival incisions are made on each quadrant between the muscles insertions. The Tenon capsule is opened with scissors to expose the sclera. Four to six cryo-applications are made per quadrant, at the edge of muscle insertion and a line behind. The exposure time is 4 to 5 seconds. 7-0 resorbable sutures are then put on each quadrant to close the conjunctiva.

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba University Hospital - Ophthalmology Department	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
Khairallah Moncef

Country where clinical trial is conducted

Tunisia, 

References & Publications (3)

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. — View Citation

Lim AS, Ang BC. Cryoapplication in diabetic retinopathy. Int Ophthalmol. 1986 May;9(2-3):139-41. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total surgical time	Duration of vitrectomy from the placement of the trocars until their removal	at the end of the vitrectomy
Primary	Intraoperative bleeding	occurrence of intravitreal bleeding during vitrectomy	at the end of the vitrectomy
Secondary	Postoperative bleeding	occurrence of intravitreal bleeding after vitrectomy	one month after the vitrectomy
Secondary	Visual acuity	Best corrected logMAR visual acuity	one month after the vitrectomy