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Completed

NCT Number: NCT04153253

Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alhadi Hospital

Hawalli, Aljabyria, 123, Kuwait

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aflibercept Injection [Eylea]

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.

Vitrectomy

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.

Primary outcomes

  1. Mean best corrected visual acuity(BCVA) change in both groups.

    Time frame: 9 months follow up.

    Final BCVA change measured in log MAR compared to initial BCVA.

Secondary outcomes

  1. Rate of recurrent bleeding.

    Time frame: 9 months follow up.

    Rate of recurrent vitreous hemorrhage in both groups after initial clearance.

  2. Number of additional treatment procedures .

    Time frame: 9 months follow up

    Additional treatment procedures done in cases of recurrent hemorrhage in both groups.

Sponsors and collaborators

Lead sponsor

Al Hadi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2019
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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