Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

Diabetic Vitreous Hemorrhage Clinical Trial

Official title:

Intravitreal Aflibercept Injection With Panretinal Photocoagulation Versus Early Vitrectomy for Diabetic Vitreous Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153253
• Other study ID #: 003-19
• Status: Completed
• Phase: Phase 4
• Start date: March 7, 2018
• Est. completion date: September 29, 2019

Study information

• Verified date: January 2020
• Source: Al Hadi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.

Description:

Selected patients were divided into two groups, Group I for whom intravitreal aflibercept injection followed by panretinal photocoagulation was done and group II for whom early vitrectomy was done.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 29, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18 years.

• Any sex.

• Type ? or ?? DM,

• recent diabetic VH which is causing vision impairment, precluding complete PRP and needing treatment.

• BCVA is less than 20/70 (log MAR BCVA 0.6) and better than 20/1000 (log MAR BCVA 1.7).

Exclusion Criteria:

• Tractional retinal detachment.

• Previous PRP.

• History of anti VEGF therapy within the past two months.

• Neovascular glaucoma

• Subhyaloid hemorrhage.

• Vitreomacular traction.

• Diabetic macular edema .

• Patients with systemic contraindications for anti VEGF or unstable medical conditions as uncontrolled hypertension (persistently above 180/110 mmhg) or recent thromboembolic event within the past six months.

Related Conditions & MeSH terms

• Diabetic Vitreous Hemorrhage
• Hemorrhage
• Vitreous Hemorrhage

Intervention

Drug:
• Aflibercept Injection [Eylea]
Three monthly based intravitreal injections were given followed by PRP if the hemorrhage was sufficiently cleared.Intravitreal injection was done in sterile operating room, after sterilization and toweling with application of sterile speculum, Betadine 5% drops was instilled into the conjunctiva and kept for two minutes followed by wash with balanced salt solution. Injection of 2mg /0.05m aflibercept was given 4 mm from the limbus in phakic eyes and 3.5 mm in pseudophakic with compression by sterile cotton tip on the site of injection, Paracentesis was done in cases of very high IOP following injection. At the end of procedure check of visual acuity was done (to be at least light perception). PRP was done if the hemorrhage is sufficiently cleared after the third injection.

Procedure:
• Vitrectomy
Was done under local peribulbar anesthesia. After sterilization and toweling, wash with diluted betadine 5% was done. Insertion of three 23 valved cannulas beginning with the lower temporal one for infusion, clearance of anterior vitreous was done followed by core vitrectomy, peripheral vitrectomy , removal of posterior hyaloid aided by triamcinolone staining , trimming and removal of any vascular epicenters followed by vitreous base shaving with 360 scleral indentation, endolaser treatment was done for all eyes followed by fluid air exchange, 20% SF6 was used only if there is active significant bleeding during surgery or if there is intraoperative retinal tears, removal of cannulas was done at the end of surgery. All eyes received combination of topical steroid and antibiotic eye drops as postoperative treatment.

Locations

Country	Name	City	State
Kuwait	Alhadi Hospital	?awalli	Aljabyria

Sponsors (1)

Lead Sponsor	Collaborator
Al Hadi Hospital

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean best corrected visual acuity(BCVA) change in both groups.	Final BCVA change measured in log MAR compared to initial BCVA.	9 months follow up.
Secondary	Rate of recurrent bleeding.	Rate of recurrent vitreous hemorrhage in both groups after initial clearance.	9 months follow up.
Secondary	Number of additional treatment procedures .	Additional treatment procedures done in cases of recurrent hemorrhage in both groups.	9 months follow up