Back to resultsEndolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH (LASERLESS)
Primary Purpose
Proliferative Diabetic Retinopathy
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aflibercept
Endolaserless Vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Proliferative Diabetic Retinopathy, Aflibercept, Vitreous Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Southeast Retina Center, PCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IAI q8 week Group
IAI q16 week Group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
• 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.
Secondary Outcome Measures
Mean change in BCVA letter score
Mean change in BCVA letter score over time through week 52
Mean BCVA letter score
Mean BCVA letter score over time through week 52
Proportion of eyes with progression of PDR
Proportion of eyes with progression of PDR as defined above at any time point through week 52
Mean OCT CSF thickness
Mean OCT CSF thickness over time through week 52
Proportion of eyes with OCT CSF thickness <300um
Proportion of eyes with OCT CSF thickness <300um at week 52
Proportion of eyes with absence of Optos widefield fluorescein angiographic macular leakage
Proportion of eyes with absence of Optos widefield fluorescein angiographic macular leakage at week 52
Proportion of eyes with absence of active neovascularization
Proportion of eyes with absence of active neovascularization by Optos widefield fluorescein angiography at week 52
Proportion of eyes with absence of active neovascularization
Proportion of eyes with absence of active neovascularization by 7 standard field photography at week 52
Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic macular leakage
Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic macular leakage from baseline angiograms at week 52
Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic neovascularization
Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic neovascularization from baseline angiograms at week 52
Proportion of eyes with unchanged, worsened, or improved fundus photographic DME appearance
Proportion of eyes with unchanged, worsened, or improved fundus photographic DME appearance from baseline photographs at week 52
Mean cumulative score and change for the combined 30-2 and 60-4 HVF test
Mean cumulative score and change for the combined 30-2 and 60-4 HVF test from week 4 to week 52.
Proportion of eyes requiring additional IAI other than mandatory injections
Proportion of eyes requiring additional IAI other than mandatory injections through week 52
Proportion of eye with progression of PDR requiring rescue PRP standard of care
Proportion of eye with progression of PDR requiring rescue PRP standard of care at any time point through 52 weeks
Proportion of eyes requiring PRP or retinopexy
Proportion of eyes requiring PRP or retinopexy through week 52
Proportion of eyes requiring additional vitrectomy
Proportion of eyes requiring additional vitrectomy through week 52
Proportion of enrolled eyes requiring intraoperative endolaser in a PRP pattern at the time of initial vitrectomy
Proportion of enrolled eyes requiring intraoperative endolaser in a PRP pattern at the time of initial vitrectomy
Full Information
NCT ID
NCT02976012
First Posted
November 4, 2015
Last Updated
November 23, 2016
Sponsor
Southeast Retina Center, Georgia
1. Study Identification
Unique Protocol Identification Number
NCT02976012
Brief Title
Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH
Acronym
LASERLESS
Official Title
Endolaserless Vitrectomy With Intravitreal Aflibercept Injection for Proliferative Diabetic Retinopathy-Related Vitreous Hemorrhage (LASER LESS TRIAL)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast Retina Center, Georgia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
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 intravitreal aflibercept 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).
Follow-up visits occur 1 day and 1-2 weeks, and 4 weeks postoperatively and then every 4 weeks from the first postoperative IAI for 52 weeks. One preoperative visit and every postoperative visit (except day one postoperatively) will include ETDRS Best Corrected Visual Acuity (BCVA), Intraocular Pressure (IOP) measurement, Slit lamp biomicroscopy, Indirect ophthalmoscopy, Heidelberg Spectralis Spectral Domain Optical Coherence Tomography (SD-OCT) (no OCT for preoperative visit) and evaluation for systemic and ocular adverse events. Seven standard field photographs and Optos wide-field fluorescein angiography will be performed at postoperative visits at 4, 16, 28, 40,and 52 weeks. Humphrey visual field (HVF) testing (30-2 and 60-4 test patterns) will be performed at postoperative visits at 4 and 52 weeks. Preoperative B scan echography will be required standard of care(SOC) to assess for macular traction, non-macular traction, retinal detachment and vitreous hemorrhage(VH). Identification of traction macular detachment will exclude the patient from the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
Proliferative Diabetic Retinopathy, Aflibercept, Vitreous Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IAI q8 week Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
IAI q16 week Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea, 2 mg/0.05 mL single use vial for intravitreal injection
Intervention Description
. 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.
Intervention Type
Procedure
Intervention Name(s)
Endolaserless Vitrectomy
Intervention Description
Endolaserless vitrectomy and intraoperative and postoperative IAI in patients with PDR-related vitreous hemorrhage
Primary Outcome Measure Information:
Title
• Ocular and systemic safety evaluation for adverse events at any time point through 52 weeks:
Description
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.
Time Frame
Through 52 weeks from Baseline
Secondary Outcome Measure Information:
Title
Mean change in BCVA letter score
Description
Mean change in BCVA letter score over time through week 52
Time Frame
52 weeks from Baseline
Title
Mean BCVA letter score
Description
Mean BCVA letter score over time through week 52
Time Frame
52 weeks from Baseline
Title
Proportion of eyes with progression of PDR
Description
Proportion of eyes with progression of PDR as defined above at any time point through week 52
Time Frame
Through 52 weeks from Baseline
Title
Mean OCT CSF thickness
Description
Mean OCT CSF thickness over time through week 52
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eyes with OCT CSF thickness <300um
Description
Proportion of eyes with OCT CSF thickness <300um at week 52
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eyes with absence of Optos widefield fluorescein angiographic macular leakage
Description
Proportion of eyes with absence of Optos widefield fluorescein angiographic macular leakage at week 52
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eyes with absence of active neovascularization
Description
Proportion of eyes with absence of active neovascularization by Optos widefield fluorescein angiography at week 52
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eyes with absence of active neovascularization
Description
Proportion of eyes with absence of active neovascularization by 7 standard field photography at week 52
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic macular leakage
Description
Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic macular leakage from baseline angiograms at week 52
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic neovascularization
Description
Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic neovascularization from baseline angiograms at week 52
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eyes with unchanged, worsened, or improved fundus photographic DME appearance
Description
Proportion of eyes with unchanged, worsened, or improved fundus photographic DME appearance from baseline photographs at week 52
Time Frame
Through 52 weeks from Baseline
Title
Mean cumulative score and change for the combined 30-2 and 60-4 HVF test
Description
Mean cumulative score and change for the combined 30-2 and 60-4 HVF test from week 4 to week 52.
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eyes requiring additional IAI other than mandatory injections
Description
Proportion of eyes requiring additional IAI other than mandatory injections through week 52
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eye with progression of PDR requiring rescue PRP standard of care
Description
Proportion of eye with progression of PDR requiring rescue PRP standard of care at any time point through 52 weeks
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eyes requiring PRP or retinopexy
Description
Proportion of eyes requiring PRP or retinopexy through week 52
Time Frame
Through 52 weeks from Baseline
Title
Proportion of eyes requiring additional vitrectomy
Description
Proportion of eyes requiring additional vitrectomy through week 52
Time Frame
Through 52 weeks from Baseline
Title
Proportion of enrolled eyes requiring intraoperative endolaser in a PRP pattern at the time of initial vitrectomy
Description
Proportion of enrolled eyes requiring intraoperative endolaser in a PRP pattern at the time of initial vitrectomy
Time Frame
Through 52 weeks from Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis M Marcus, MD
Phone
706-650-0061
Email
dmarcus@southeastretina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Siobhan Ortiz
Phone
706-650-0061
Email
siobhan@southeastretina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis M Marcus, MD
Organizational Affiliation
Southeast Retina Center, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast Retina Center, PC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siobhan Ortiz
Phone
706-650-0061
First Name & Middle Initial & Last Name & Degree
Dennis M Marcus, MD
Phone
706-650-0061
Email
dmarcus@southeastretina.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH
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