Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

NCT ID: NCT04153253

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2019-09-29

Brief Summary

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

Detailed 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.

Conditions

Diabetic Vitreous Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I

Intravitreal injection of Aflibercept followed by panretinal photocoagulation.

Group Type: ACTIVE_COMPARATOR

Aflibercept Injection [Eylea]

Intervention Type: DRUG

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.

Group II: Early vitrectomy.

Early vitrectomy.

Group Type: ACTIVE_COMPARATOR

Vitrectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age above 18 years.
• Any sex.
• Type Ι or ΙΙ 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al Hadi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Abeer MohamedSadeck Khattab

Abeer Mohamed Sadeck Khattab ,associate professor of ophthalmology.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed H Abdelhamid, MD

Role: STUDY_DIRECTOR

Alhadi hospital

Locations

Alhadi Hospital

Hawalli, Aljabyria, Kuwait

Countries

Kuwait

References

Abd Elhamid AH, Mohamed AAEA, Khattab AM. Intravitreal Aflibercept injection with Panretinal photocoagulation versus early Vitrectomy for diabetic vitreous hemorrhage: randomized clinical trial. BMC Ophthalmol. 2020 Apr 6;20(1):130. doi: 10.1186/s12886-020-01401-4.

Reference Type: DERIVED

PMID: 32252674 (View on PubMed)

Other Identifiers

003-19

Identifier Type: -

Identifier Source: org_study_id