Recruiting
Phase 1
Phase 2

Endolaserless Vitrectomy

Sponsor:

Southeast Retina Center, Georgia

Code:

NCT02976012

Conditions

Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Aflibercept

Endolaserless Vitrectomy

Study Details

Brief summary:

This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will receive one preoperative intravitreal aflibercept injection (IAI) <21 days but >7 days prior to vitrectomy and one intraoperative IAI at end of surgery followed by randomization in a 1:1 ratio into either 4 mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative q4weeks IAI followed by mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).

Conditions

Proliferative Diabetic Retinopathy

Study ID

NCT02976012

Start date

Jun, 2016

Status verified date

Nov, 2016

Completion date

Jun, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Adults age >18 years with Diabetes Mellitus
2. PDR- related vitreous hemorrhage and not of another cause
3. BCVA Vision LP or better
4. Investigator determination that vitrectomy indicated for PDR-related vitreous hemorrhage
5. Willing and able to comply with clinic visits and study-related procedures
6. Provide HIPPA and signed informed consent prior to any study procedures

Exclusion Criteria:

1. A condition per investigator opinion, would preclude participation in the study (unstable medical status, cardiovascular disease, glycemic control, inability to follow up etc.)
2. Participation in an investigational trial within 30 days of enrollment
3. Known allergy to IAI
4. Systemic anti-VEGF or pro-VEGF treatment within 4 months of enrollment
5. For women of childbearing age, pregnant or lactating or intending to become pregnant within the next 3 years
6. History of PRP or peripheral retinal cryopexy or peripheral retinopexy for any reason in the study eye
7. History of vitrectomy in the study eye
8. History or evidence for rhegmatogenous retinal detachment in the study eye
9. Evidence of traction retinal detachment involving or threatening central macula in the study eye
10. Exam evident of external ocular infection (i.e. conjunctivitis, significant blepharitis, chalazion etc)
11. Intravitreal anti-VEGF injection in the study eye <4weeks from enrollment.
12. Pregnant or breast-feeding women
13. Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) \*Contraception is not required for men with documented vasectomy. \*\*Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: IAI q8 week Group

Eyes will be randomized on the day of endolaserless vitrectomy surgery or first postoperative 1-2 week visit to a group ("q8 week Group") where 4 additional mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI for 52 weeks follow-up. Starting at week 20 in the q8week group eyes may be eligible to receive additional 2mg IAI (intravitreal aflibercept) (monthly) treatment

active comparator: IAI q16 week Group

Eyes will be randomized on the day of endolaserless vitrectomy surgery or first postoperative 1-2 week visit to a group (q16week Group) where 2 additional mandatory postoperative q4weeks IAI will be followed by mandatory q16weeks IAI for 52 weeks follow-up. Starting at week 12 in the q16 group, eyes may be eligible to receive additional 2mg IAI (intravitreal aflibercept) (monthly) treatment.

Interventions

Aflibercept

. Study eyes will receive one preoperative intravitreal aflibercept injection (IAI) <21 days prior to vitrectomy and one intraoperative intravitreal aflibercept at end of surgery. Eyes will be randomized on the day of surgery or 1-2 weeks post-operatively to either a q8week IAI dosing regimen group or a q16week IAI dosing regimen group.

Endolaserless Vitrectomy

Endolaserless vitrectomy and intraoperative and postoperative IAI in patients with PDR-related vitreous hemorrhage

Primary outcome measure

  • • Ocular and systemic safety evaluation for adverse events at any time point through 52 weeks: [ Time Frame: Through 52 weeks from Baseline ]

Central Contacts and Locations

Locations

Southeast Retina Center, PC

Recruiting

Augusta, Georgia, United States, 30809

Contacts

More Information

Sponsor

Southeast Retina Center, Georgia

Last update posted

Nov 29, 2016

Last verified

Nov, 2016

Keywords

  • Proliferative Diabetic Retinopathy
  • Aflibercept
  • Vitreous Hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southeast Retina Center, Georgia on 2016-11-29.