Use of Ziv Aflibercept in Different Retinal Diseases

Central Retinal Vein Occlusion With Macular Edema Clinical Trial

Official title:

Safety and Efficacy of Ziv Aflibercept in Myopic Choroidal Neovascularisation ,Central Retinal Vein Occlusion and Resistant Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290195
• Other study ID #: 2AA
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: October 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective interventional case series study was conducted on 20 eyes of 20 patients with active myopic choroidal neovascularisation (CNV) ,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic central retinal vein occlusion(CRVO) after approval of the Ethical Committee of the Faculty of Medicine, Tanta University . All procedures were carried out under the tenets of the Helsinki Declaration. Written consent was provided by all participants after discussing the procedure, alternative treatment plans, follow-up schedules, and possible benefits and risks.

Description:

Intravitreal injection of 1.25 mg of ziv aflibercept was done in different retinal diseases including myopic CVN,resistant diabetic macular edema to previous ranibizumab injection and non ischaemic CRVO .Thorough ophthalmic evaluation was done including BCVA(best corrected visual acuity) ,anterior and posterior segment examination ,fundus fluorescein angiography and OCT(optical coherence tomography) were performed for all patients .Injection was repeated as PRN(pro re nata) method after one month if persistent intraretinal or subretinal fluid was found.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 31 Years to 63 Years

Eligibility

Inclusion Criteria:

• The study included treatment naive patients suffering from recently diagnosed active myopic subfoveal or juxtafoveal CNV less than 2 months documented by fundus fluorescein angiography (FFA)and optical coherence tomography (OCT ) , pathological myopia more than 6 D was included .

Exclusion Criteria:

• Previous intraocular surgery .

• Coincident retinal pathology as diabetic retinopathy, retinal vein occlusion .

• CNV due to other causes like age related macular degeneration ,angioid streaks,trauma and choroiditis.

• Extrafoveal myopic CNV .

• Patients received other lines of treatment for CNV like photodynamic therapy ,laser photocoagulation or intravitreal injection of triamcinolone or other anti VEGF(vascular endothelial growth factor) agents.

• Known glaucoma , clinical suspicion of glaucoma or IOP(intraocular pressure) more than 20 mmHg.

• Prior ocular inflammation.

• The presence of retinal degeneration.

• Patients who didnot complete 6 months of follow up

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion With Macular Edema
• Choroidal Neovascularization
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ziv-Aflibercept 25 MG/ML [Zaltrap]
Intravitreal injection of 1.25 mg of ziv aflibercept in patients

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El Gharbia

Sponsors (2)

Lead Sponsor	Collaborator
Amin El Sayed Nawar	Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Chan WM, Ohji M, Lai TY, Liu DT, Tano Y, Lam DS. Choroidal neovascularisation in pathological myopia: an update in management. Br J Ophthalmol. 2005 Nov;89(11):1522-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of BCVA by log MAR(minimum angle of resolution) and reduction of CMT after intravitreal injection	To assess sustained improvement of BCVA(Best corrected visual acuity) and reduction of the CMT (central macular thickness) after intravitreal injection of zivaflibercept	6 months

External Links

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