Proliferative Diabetic RetinopathyPhase 1/2LASERLESSNCT02976012
Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH
A Phase 1/2 study testing Aflibercept and Endolaserless Vitrectomy in people with Proliferative Diabetic Retinopathy, run by Southeast Retina Center, Georgia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Aflibercept and Endolaserless Vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southeast Retina Center, PC
Augusta, Georgia, 30809
Siobhan Ortiz, 706-650-0061
Dennis M Marcus, MD, 706-650-0061, dmarcus@southeastretina.com
About this study
Official title: Endolaserless Vitrectomy With Intravitreal Aflibercept Injection for Proliferative Diabetic Retinopathy-Related Vitreous Hemorrhage (LASER LESS TRIAL)
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).
Read the 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.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Aflibercept, Endolaserless Vitrectomy
- Keywords
- Proliferative Diabetic Retinopathy, Aflibercept, Vitreous Hemorrhage
- Medical subject headings
- Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Also called Eylea, 2 mg/0.05 mL single use vial for intravitreal injection
. 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 VitrectomyProcedure or surgery
Endolaserless vitrectomy and intraoperative and postoperative IAI in patients with PDR-related vitreous hemorrhage
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Aflibercept; Procedure: Endolaserless Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: Through 52 weeks from Baseline
Secondary outcomes (17)
Mean change in BCVA letter score
Mean change in BCVA letter score over time through week 52
Measured: 52 weeks from Baseline
Mean BCVA letter score
Mean BCVA letter score over time through week 52
Measured: 52 weeks from Baseline
Proportion of eyes with progression of PDR
Proportion of eyes with progression of PDR as defined above at any time point through week 52
Measured: Through 52 weeks from Baseline
Mean OCT CSF thickness
Mean OCT CSF thickness over time through week 52
Measured: Through 52 weeks from Baseline
Proportion of eyes with OCT CSF thickness <300um
Proportion of eyes with OCT CSF thickness <300um at week 52
Measured: Through 52 weeks from Baseline
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
Measured: Through 52 weeks from Baseline
Proportion of eyes with absence of active neovascularization
Proportion of eyes with absence of active neovascularization by Optos widefield fluorescein angiography at week 52
Measured: Through 52 weeks from Baseline
Proportion of eyes with absence of active neovascularization
Proportion of eyes with absence of active neovascularization by 7 standard field photography at week 52
Measured: Through 52 weeks from Baseline
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
Measured: Through 52 weeks from Baseline
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
Measured: Through 52 weeks from Baseline
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
Measured: Through 52 weeks from Baseline
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.
Measured: Through 52 weeks from Baseline
Proportion of eyes requiring additional IAI other than mandatory injections
Proportion of eyes requiring additional IAI other than mandatory injections through week 52
Measured: Through 52 weeks from Baseline
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
Measured: Through 52 weeks from Baseline
Proportion of eyes requiring PRP or retinopexy
Proportion of eyes requiring PRP or retinopexy through week 52
Measured: Through 52 weeks from Baseline
Proportion of eyes requiring additional vitrectomy
Proportion of eyes requiring additional vitrectomy through week 52
Measured: Through 52 weeks from Baseline
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
Measured: Through 52 weeks from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast Retina Center, Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis M. Marcus, M.D., Southeast Retina Center, Georgia
- Investigators
- Dennis M Marcus, MD, Principal investigator, Southeast Retina Center, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976012
- Sponsor's protocol ID
- VGFTe-DR-1548
- Acronym
- LASERLESS
- Status last verified
- Nov 2016
- First submitted
- 4 Nov 2015
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endolaserless Vitrectomy With Intravitreal Aflibercept Injection for Proliferative Diabetic Retinopathy-Related Vitreous Hemorrhage (LASER LESS TRIAL)
- ClinicalTrials.gov ID
- NCT02976012
- Acronym / sponsor ID
- LASERLESS / VGFTe-DR-1548
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Proliferative Diabetic Retinopathy, Aflibercept, Vitreous Hemorrhage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Southeast Retina Center, GeorgiaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IAI q8 week Group | Active comparator | Drug: Aflibercept, Procedure: Endolaserless VitrectomyEyes 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 |
| IAI q16 week Group | Active comparator | Drug: Aflibercept, Procedure: Endolaserless VitrectomyEyes 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfliberceptAlso: Eylea, 2 mg/0.05 mL single use vial for intravitreal injection. 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. | Drug | IAI q16 week Group, IAI q8 week Group |
| Endolaserless VitrectomyEndolaserless vitrectomy and intraoperative and postoperative IAI in patients with PDR-related vitreous hemorrhage | Procedure or surgery | IAI q16 week Group, IAI q8 week Group |
Primary outcome
• Ocular and systemic safety evaluation for adverse events at any time point through 52 weeks:
Time frame: Through 52 weeks from Baseline
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.
17 secondary outcomes
Mean change in BCVA letter score
Time frame: 52 weeks from Baseline
Mean BCVA letter score
Time frame: 52 weeks from Baseline
Proportion of eyes with progression of PDR
Time frame: Through 52 weeks from Baseline
Mean OCT CSF thickness
Time frame: Through 52 weeks from Baseline
Proportion of eyes with OCT CSF thickness <300um
Time frame: Through 52 weeks from Baseline
Proportion of eyes with absence of Optos widefield fluorescein angiographic macular leakage
Time frame: Through 52 weeks from Baseline
Proportion of eyes with absence of active neovascularization
Time frame: Through 52 weeks from Baseline
Proportion of eyes with absence of active neovascularization
Time frame: Through 52 weeks from Baseline
Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic macular leakage
Time frame: Through 52 weeks from Baseline
Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic neovascularization
Time frame: Through 52 weeks from Baseline
Proportion of eyes with unchanged, worsened, or improved fundus photographic DME appearance
Time frame: Through 52 weeks from Baseline
Mean cumulative score and change for the combined 30-2 and 60-4 HVF test
Time frame: Through 52 weeks from Baseline
Proportion of eyes requiring additional IAI other than mandatory injections
Time frame: Through 52 weeks from Baseline
Proportion of eye with progression of PDR requiring rescue PRP standard of care
Time frame: Through 52 weeks from Baseline
Proportion of eyes requiring PRP or retinopexy
Time frame: Through 52 weeks from Baseline
Proportion of eyes requiring additional vitrectomy
Time frame: Through 52 weeks from Baseline
Proportion of enrolled eyes requiring intraoperative endolaser in a PRP pattern at the time of initial vitrectomy
Time frame: Through 52 weeks from Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis M Marcus, MD principal investigator
Southeast Retina Center, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aflibercept and Endolaserless Vitrectomy in people with Proliferative Diabetic Retinopathy, run by Southeast Retina Center, Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis M Marcus, MD (706-650-0061, dmarcus@southeastretina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.