Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH

NCT02976012 | Unknown Phase 1

• 1 other identifier: VGFTe-DR-1548
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Proliferative Diabetic Retinopathy; Aflibercept; Vitreous Hemorrhage

Outcome Measures

Primary Outcomes (1)

• • Ocular and systemic safety evaluation for adverse events at any time point through 52 weeks:

  Examples include worsened acuity \>30 letters, rhegmatogenous or tractional retinal detachment, endophthalmitis, new or increased vitreous hemorrhage, cataract progression or surgery, need for additional vitrectomy or scleral buckle, development of new DME after OCT documentation of absence of DME, systemic thromboembolic events, deaths and systemic serious adverse events at any time point through week 52.

  Through 52 weeks from Baseline

Secondary Outcomes (17)

• Mean change in BCVA letter score

  52 weeks from Baseline

• Mean BCVA letter score

  52 weeks from Baseline

• Proportion of eyes with progression of PDR

  Through 52 weeks from Baseline

• Mean OCT CSF thickness

  Through 52 weeks from Baseline

• Proportion of eyes with OCT CSF thickness <300um

  Through 52 weeks from Baseline

Study Arms (2)

IAI q8 week Group

ACTIVE COMPARATOR

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

Drug: Aflibercept; Procedure: Endolaserless Vitrectomy

IAI q16 week Group

ACTIVE COMPARATOR

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.

Drug: Aflibercept; Procedure: Endolaserless Vitrectomy

Interventions

Aflibercept DRUG

. 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.

Also known as: Eylea, 2 mg/0.05 mL single use vial for intravitreal injection

IAI q16 week Group; IAI q8 week Group

Endolaserless Vitrectomy PROCEDURE

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

IAI q16 week Group; IAI q8 week Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• A condition per investigator opinion, would preclude participation in the study (unstable medical status, cardiovascular disease, glycemic control, inability to follow up etc.)
• Participation in an investigational trial within 30 days of enrollment
• Known allergy to IAI
• Systemic anti-VEGF or pro-VEGF treatment within 4 months of enrollment
• For women of childbearing age, pregnant or lactating or intending to become pregnant within the next 3 years
• History of PRP or peripheral retinal cryopexy or peripheral retinopexy for any reason in the study eye
• History of vitrectomy in the study eye
• History or evidence for rhegmatogenous retinal detachment in the study eye
• Evidence of traction retinal detachment involving or threatening central macula in the study eye
• Exam evident of external ocular infection (i.e. conjunctivitis, significant blepharitis, chalazion etc)
• Intravitreal anti-VEGF injection in the study eye \<4weeks from enrollment.
• Pregnant or breast-feeding women
• 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.

Sponsors & Collaborators

• Southeast Retina Center, Georgia: lead

Study Sites (1)

Southeast Retina Center, PC

Augusta, Georgia, 30809, United States

RECRUITING

MeSH Terms

Conditions

Vitreous Hemorrhage

Interventions

aflibercept; Intravitreal Injections

Condition Hierarchy (Ancestors)

Eye Hemorrhage; Eye Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dennis M Marcus, MD

  Southeast Retina Center, PC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis M Marcus, MD

CONTACT

706-650-0061; dmarcus@southeastretina.com

Siobhan Ortiz

CONTACT

706-650-0061; siobhan@southeastretina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 29, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 29, 2016

Record last verified: 2016-11

Locations

US (1)