Diabetic RetinopathyEarly Phase 1PTDMENCT02457975
Photobiomodulation for the Treatment of Diabetic Macular Edema
A Early Phase 1 study testing 670nm PBM and intravitreous VEGF-inhibitors in people with Diabetic Retinopathy, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The current application proposes to conduct a prospective, clinical trial in diabetic subjects with diabetic macular edema (DME) to evaluate the therapeutic efficacy of 670 nm photobiomodulation on validated clinical outcome measures and anatomical changes in central macula by optical coherence tomography (OCT) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- 670nm PBM and intravitreous VEGF-inhibitors
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 30 Aug 2019
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with type 1 or 2 diabetes
Who cannot join
- Uncontrolled glaucoma; aphasia cataract precluding fundus photography; external ocular infections; previous anti-VEGF or laser treatment in the preceding 3 months in both eyes; angiographic evidence of macular ischemia macular edema glycosylated hemoglobin of more than 11.0% past medical history of chronic renal failure an arteriothrombotic event within 6 months before randomization pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin Froedert Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Near-Infrared Photobiomodulation for the Treatment of Diabetic Macular Edema
The current application proposes to conduct a prospective, clinical trial in diabetic subjects with diabetic macular edema (DME) to evaluate the therapeutic efficacy of 670 nm photobiomodulation on validated clinical outcome measures and anatomical changes in central macula by optical coherence tomography (OCT) and other imaging modalities. A total of 30 diabetic patients with treatment-refractory clinically significant diabetic macular edema will be included in this study and randomized into two equal groups. One eye per participant will be included to avoid exposure of both eyes to the study intervention. If both eyes are eligible, the eye with worse visual acuity will become the study eye. One group will be treated with standard-of-care (intravitreal anti-VEGF agent) injections. The photobiomodulaton (PBM) intervention group will be treated with the standard-of-care intravitreal anti-VEGF (vascular endothelial growth factor) injections and 670 nm PBM in one eye. Baseline functional and anatomic assessments will be made and anti-VEGF therapy will be administered as determined by the treating Ophthalmologist.
Read the detailed description
A total of 30 diabetic patients with treatment-refractory clinically significant diabetic macular edema will be included in this study and randomized into two equal groups. One eye per participant will be included to avoid exposure of both eyes to the study intervention. If both eyes are eligible, the eye with worse visual acuity will become the study eye. One group will be treated with standard-of-care (intravitreal anti-VEGF agent) injections. The PBM intervention group will be treated with the standard-of-care intravitreal anti-VEGF injections and 670 nm PBM in one eye. Baseline functional and anatomic assessments will be made and anti-VEGF therapy will be administered as determined by the treating Ophthalmologist.
Subjects in the PBM intervention arm will be treated (in addition to standard care) with 670nm light (WARP10, Quantum, Devices, Inc, Barneveld, WI). The portable, battery-operated 670 nm LED array specifically designed not to generate heat will be hand held 1 inch from the closed treatment eye. An 80-sec light treatment will be delivered. After 80 sec a timer turns off the light. The dose of light delivered at the surface of the cornea is calculated to be 4.0 J/cm2 (80 sec x 0.05 W/cm2 = 4.0 J/cm2). PBM treatment will be applied for 80 sec once per day, three consecutive days per week for 8 weeks. Previous clinical studies, have shown this treatment regimen and dose to be safe and effective in the treatment of dry AMD and non-center involving DME.
ASSESSMENTS: Subjects will undergo a detailed functional and structural evaluation at baseline and at 8 and 24 weeks. Seven-field color fundus photographs will be obtained for ETDRS retinopathy grading at baseline 8 and 24 weeks. Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) will be obtained at every visit. Fundus fluorescein angiography and Spectralis OCT scans will be obtained according to predefined protocols. Blood pressure and glycosylated hemoglobin level will be recorded at baseline and 8 and 24 weeks to identify any changes in systemic status that could affect retinopathy grade and macular edema. Cataract status will be recorded at baseline and 8 and 24 weeks as a safety measure and as a possible confounding factor for visual acuity assessment.
OUTCOME MEASURES: Functional measure will be change in ETDRS BCVA from baseline. Structural outcome measures will include changes in qualitative and quantitative OCT parameters, including macular thickness and volume in 9 ETDRS subfields, obtained from automated measures in the Heidelberg Eye Explorer software (Heidelberg Engineering GmbH, Heidelberg, Germany) without formally correcting for boundary detection error; these measures are highly reproducible. Changes in intraretinal and subretinal fluid on OCT will be evaluated. The change in ETDRS severity grade of diabetic retinopathy will be reported from 7-field color fundus photographs. Safety parameters will include the reporting of ocular and nonocular adverse events. Changes to the greatest linear dimension and area of the foveal avascular zone on fluorescein angiography, together with the degree of perifoveal capillary loss, will be reported. The grading of photographs both for retinopathy grade and foveal avascular zone measurements will be carried out by a trained and certified senior diabetic retinopathy grader at the Medical College of Wisconsin. The number of anti-VEGF treatments in the two arms will be compared as a secondary measure of effect of PBM.
- Conditions
- Diabetic Retinopathy
- Being tested
- 670nm PBM, intravitreous VEGF-inhibitors
- Keywords
- Diabetic Macular Edema, Photobiomodulation, Phototherapy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
670nm PBMDevice
Also called WARP10 by Quantum Devices, Inc (Barneveld, WI)
Battery operated, hand-held, 10 cm2 Light Emitting Diode (LED) array designed to deliver 50 mW/cm2 of light for 90 seconds resulting in a light dose of 4.5 Joules/cm2
intravitreous VEGF-inhibitorsDrug
Also called aflibercept, bevacizumab, or ranibizumab
Threeintravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used for the treatment of diabetic macular edema causing vision impairment and have been shown to be beneficial and relatively safe. Study participants in the anti-VEGF group will be treated with intravitreous injections of one of these agents: afibercept (2.0 mg), bevacizumab (1.25 mg) or ranibizumab (0.5 mg) at appropriate intervals as determined by the treating ophthalmologist.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreous VEGF-inhibitors | Active comparator | Three intravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used for the treatment of diabetic macular edema causing vision impairment and have been shown to be beneficial and relatively safe. Study participants in the anti-VEGF group will be treated with intravitreous injections of one of these agents: afibercept (2.0 mg), bevacizumab (1.25 mg) or ranibizumab (0.5 mg) at appropriate intervals as determined by the treating ophthalmologist. Receives: Drug: intravitreous VEGF-inhibitors |
| 670nm PBM plus VEGF-inhibitors | Experimental | Subjects in the 670 nm Photobiomodulation (PBM) intervention arm will be treated (in addition to Anti-VEGF treatment) with 670nm light (WARP10, Quantum, Devices, Inc, Barneveld, WI). The portable, battery-operated 670 nm LED array specifically designed not to generate heat will be held 1 inch from the closed treatment eye. A 90-sec light treatment will be delivered. After 90 sec a timer turns off the light. The dose of light delivered at the surface of the cornea is calculated to be 4.5 J/cm2 (90 sec x 0.05 W/cm2 = 4.5 J/cm2). PBM treatment will be applied for 90 sec once per day, three consecutive days per week for 8 weeks. Previous clinical studies, have shown this treatment regimen and dose to be safe and effective in the treatment of dry AMD and non-center involving DME Receives: Device: 670nm PBM; Drug: intravitreous VEGF-inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity as assessed by the Early Treatment of Diabetic Retinopathy Study (EDTRS) Classification
Measured: Change from baseline at 8 weeks; Change from baseline at 24 weeks
Secondary outcomes (1)
Spectral Density-Optical Coherence Tomography (SD-OCT)
Measured: Change from baseline at 8 weeks; Change from baseline at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJun 2015
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee
- Responsible party
- Principal investigator, Judy Kim, Medical College of Wisconsin
- Investigators
- Judy Kim, MD, Principal investigator, MCW Dept of OphthalmologySandeep Gopalakrishnan, Ph.D., Principal investigator, UW-Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457975
- Sponsor's protocol ID
- PRO00024065
- Acronym
- PTDME
- Status last verified
- Sep 2019
- First submitted
- 25 May 2015
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang X, Zeng H, Bao S, Wang N, Gillies MC. Diabetic macular edema: new concepts in patho-physiology and treatment. Cell Biosci. 2014 May 14;4:27. doi: 10.1186/2045-3701-4-27. eCollection 2014.
PubMed 24955234Falavarjani KG, Nguyen QD. Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature. Eye (Lond). 2013 Jul;27(7):787-94. doi: 10.1038/eye.2013.107. Epub 2013 May 31.
PubMed 23722722Tang J, Herda AA, Kern TS. Photobiomodulation in the treatment of patients with non-center-involving diabetic macular oedema. Br J Ophthalmol. 2014 Aug;98(8):1013-5. doi: 10.1136/bjophthalmol-2013-304477. Epub 2014 Mar 28.
PubMed 24682183Simo R, Sundstrom JM, Antonetti DA. Ocular Anti-VEGF therapy for diabetic retinopathy: the role of VEGF in the pathogenesis of diabetic retinopathy. Diabetes Care. 2014 Apr;37(4):893-9. doi: 10.2337/dc13-2002.
PubMed 24652720Eells JT, Wong-Riley MT, VerHoeve J, Henry M, Buchman EV, Kane MP, Gould LJ, Das R, Jett M, Hodgson BD, Margolis D, Whelan HT. Mitochondrial signal transduction in accelerated wound and retinal healing by near-infrared light therapy. Mitochondrion. 2004 Sep;4(5-6):559-67. doi: 10.1016/j.mito.2004.07.033.
PubMed 16120414Tang J, Du Y, Lee CA, Talahalli R, Eells JT, Kern TS. Low-intensity far-red light inhibits early lesions that contribute to diabetic retinopathy: in vivo and in vitro. Invest Ophthalmol Vis Sci. 2013 May 1;54(5):3681-90. doi: 10.1167/iovs.12-11018.
PubMed 23557732Cheung N, Wong IY, Wong TY. Ocular anti-VEGF therapy for diabetic retinopathy: overview of clinical efficacy and evolving applications. Diabetes Care. 2014 Apr;37(4):900-5. doi: 10.2337/dc13-1990.
PubMed 24652721Eells JT, Henry MM, Summerfelt P, Wong-Riley MT, Buchmann EV, Kane M, Whelan NT, Whelan HT. Therapeutic photobiomodulation for methanol-induced retinal toxicity. Proc Natl Acad Sci U S A. 2003 Mar 18;100(6):3439-44. doi: 10.1073/pnas.0534746100. Epub 2003 Mar 7.
PubMed 12626762Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2.
PubMed 22045511
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Photobiomodulation for the Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02457975
- Acronym / sponsor ID
- PTDME / PRO00024065
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Macular Edema, Photobiomodulation, Phototherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee
- Study start
- Jun 2015
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 29 May 2015 (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.
The current application proposes to conduct a prospective, clinical trial in diabetic subjects with diabetic macular edema (DME) to evaluate the therapeutic efficacy of 670 nm photobiomodulation on validated clinical outcome measures and anatomical changes in central macula by optical coherence tomography (OCT) and other imaging modalities. A total of 30 diabetic patients with treatment-refractory clinically significant diabetic macular edema will be included in this study and randomized into two equal groups. One eye per participant will be included to avoid exposure of both eyes to the study intervention. If both eyes are eligible, the eye with worse visual acuity will become the study eye. One group will be treated with standard-of-care (intravitreal anti-VEGF agent) injections. The photobiomodulaton (PBM) intervention group will be treated with the standard-of-care intravitreal anti-VEGF (vascular endothelial growth factor) injections and 670 nm PBM in one eye. Baseline functional and anatomic assessments will be made and anti-VEGF therapy will be administered as determined by the treating Ophthalmologist.
Detailed description
A total of 30 diabetic patients with treatment-refractory clinically significant diabetic macular edema will be included in this study and randomized into two equal groups. One eye per participant will be included to avoid exposure of both eyes to the study intervention. If both eyes are eligible, the eye with worse visual acuity will become the study eye. One group will be treated with standard-of-care (intravitreal anti-VEGF agent) injections. The PBM intervention group will be treated with the standard-of-care intravitreal anti-VEGF injections and 670 nm PBM in one eye. Baseline functional and anatomic assessments will be made and anti-VEGF therapy will be administered as determined by the treating Ophthalmologist.
Subjects in the PBM intervention arm will be treated (in addition to standard care) with 670nm light (WARP10, Quantum, Devices, Inc, Barneveld, WI). The portable, battery-operated 670 nm LED array specifically designed not to generate heat will be hand held 1 inch from the closed treatment eye. An 80-sec light treatment will be delivered. After 80 sec a timer turns off the light. The dose of light delivered at the surface of the cornea is calculated to be 4.0 J/cm2 (80 sec x 0.05 W/cm2 = 4.0 J/cm2). PBM treatment will be applied for 80 sec once per day, three consecutive days per week for 8 weeks. Previous clinical studies, have shown this treatment regimen and dose to be safe and effective in the treatment of dry AMD and non-center involving DME.
ASSESSMENTS: Subjects will undergo a detailed functional and structural evaluation at baseline and at 8 and 24 weeks. Seven-field color fundus photographs will be obtained for ETDRS retinopathy grading at baseline 8 and 24 weeks. Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) will be obtained at every visit. Fundus fluorescein angiography and Spectralis OCT scans will be obtained according to predefined protocols. Blood pressure and glycosylated hemoglobin level will be recorded at baseline and 8 and 24 weeks to identify any changes in systemic status that could affect retinopathy grade and macular edema. Cataract status will be recorded at baseline and 8 and 24 weeks as a safety measure and as a possible confounding factor for visual acuity assessment.
OUTCOME MEASURES: Functional measure will be change in ETDRS BCVA from baseline. Structural outcome measures will include changes in qualitative and quantitative OCT parameters, including macular thickness and volume in 9 ETDRS subfields, obtained from automated measures in the Heidelberg Eye Explorer software (Heidelberg Engineering GmbH, Heidelberg, Germany) without formally correcting for boundary detection error; these measures are highly reproducible. Changes in intraretinal and subretinal fluid on OCT will be evaluated. The change in ETDRS severity grade of diabetic retinopathy will be reported from 7-field color fundus photographs. Safety parameters will include the reporting of ocular and nonocular adverse events. Changes to the greatest linear dimension and area of the foveal avascular zone on fluorescein angiography, together with the degree of perifoveal capillary loss, will be reported. The grading of photographs both for retinopathy grade and foveal avascular zone measurements will be carried out by a trained and certified senior diabetic retinopathy grader at the Medical College of Wisconsin. The number of anti-VEGF treatments in the two arms will be compared as a secondary measure of effect of PBM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreous VEGF-inhibitors | Active comparator | Drug: intravitreous VEGF-inhibitorsThree intravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used for the treatment of diabetic macular edema causing vision impairment and have been shown to be beneficial and relatively safe. Study participants in the anti-VEGF group will be treated with intravitreous injections of one of these agents: afibercept (2.0 mg), bevacizumab (1.25 mg) or ranibizumab (0.5 mg) at appropriate intervals as determined by the treating ophthalmologist. |
| 670nm PBM plus VEGF-inhibitors | Experimental | Device: 670nm PBM, Drug: intravitreous VEGF-inhibitorsSubjects in the 670 nm Photobiomodulation (PBM) intervention arm will be treated (in addition to Anti-VEGF treatment) with 670nm light (WARP10, Quantum, Devices, Inc, Barneveld, WI). The portable, battery-operated 670 nm LED array specifically designed not to generate heat will be held 1 inch from the closed treatment eye. A 90-sec light treatment will be delivered. After 90 sec a timer turns off the light. The dose of light delivered at the surface of the cornea is calculated to be 4.5 J/cm2 (90 sec x 0.05 W/cm2 = 4.5 J/cm2). PBM treatment will be applied for 90 sec once per day, three consecutive days per week for 8 weeks. Previous clinical studies, have shown this treatment regimen and dose to be safe and effective in the treatment of dry AMD and non-center involving DME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with type 1 or 2 diabetes
Key exclusion criteria (1 listed)
- Uncontrolled glaucoma; aphasia cataract precluding fundus photography; external ocular infections; previous anti-VEGF or laser treatment in the preceding 3 months in both eyes; angiographic evidence of macular ischemia macular edema glycosylated hemoglobin of more than 11.0% past medical history of chronic renal failure an arteriothrombotic event within 6 months before randomization pregnancy or breastfeeding.
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 |
|---|---|---|
| 670nm PBMAlso: WARP10 by Quantum Devices, Inc (Barneveld, WI)Battery operated, hand-held, 10 cm2 Light Emitting Diode (LED) array designed to deliver 50 mW/cm2 of light for 90 seconds resulting in a light dose of 4.5 Joules/cm2 | Device | 670nm PBM plus VEGF-inhibitors |
| intravitreous VEGF-inhibitorsAlso: aflibercept, bevacizumab, or ranibizumabThreeintravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used for the treatment of diabetic macular edema causing vision impairment and have been shown to be beneficial and relatively safe. Study participants in the anti-VEGF group will be treated with intravitreous injections of one of these agents: afibercept (2.0 mg), bevacizumab (1.25 mg) or ranibizumab (0.5 mg) at appropriate intervals as determined by the treating ophthalmologist. | Drug | 670nm PBM plus VEGF-inhibitors, Intravitreous VEGF-inhibitors |
Primary outcome
Visual Acuity as assessed by the Early Treatment of Diabetic Retinopathy Study (EDTRS) Classification
Time frame: Change from baseline at 8 weeks; Change from baseline at 24 weeks
1 secondary outcome
Spectral Density-Optical Coherence Tomography (SD-OCT)
Time frame: Change from baseline at 8 weeks; Change from baseline at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Background: PubMed 24955234Zhang X, Zeng H, Bao S, Wang N, Gillies MC. Diabetic macular edema: new concepts in patho-physiology and treatment. Cell Biosci. 2014 May 14;4:27. doi: 10.1186/2045-3701-4-27. eCollection 2014.
- Background: PubMed 23722722Falavarjani KG, Nguyen QD. Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature. Eye (Lond). 2013 Jul;27(7):787-94. doi: 10.1038/eye.2013.107. Epub 2013 May 31.
- Background: PubMed 24682183Tang J, Herda AA, Kern TS. Photobiomodulation in the treatment of patients with non-center-involving diabetic macular oedema. Br J Ophthalmol. 2014 Aug;98(8):1013-5. doi: 10.1136/bjophthalmol-2013-304477. Epub 2014 Mar 28.
- Background: PubMed 24652720Simo R, Sundstrom JM, Antonetti DA. Ocular Anti-VEGF therapy for diabetic retinopathy: the role of VEGF in the pathogenesis of diabetic retinopathy. Diabetes Care. 2014 Apr;37(4):893-9. doi: 10.2337/dc13-2002.
- Background: PubMed 16120414Eells JT, Wong-Riley MT, VerHoeve J, Henry M, Buchman EV, Kane MP, Gould LJ, Das R, Jett M, Hodgson BD, Margolis D, Whelan HT. Mitochondrial signal transduction in accelerated wound and retinal healing by near-infrared light therapy. Mitochondrion. 2004 Sep;4(5-6):559-67. doi: 10.1016/j.mito.2004.07.033.
- Background: PubMed 23557732Tang J, Du Y, Lee CA, Talahalli R, Eells JT, Kern TS. Low-intensity far-red light inhibits early lesions that contribute to diabetic retinopathy: in vivo and in vitro. Invest Ophthalmol Vis Sci. 2013 May 1;54(5):3681-90. doi: 10.1167/iovs.12-11018.
- Background: PubMed 24652721Cheung N, Wong IY, Wong TY. Ocular anti-VEGF therapy for diabetic retinopathy: overview of clinical efficacy and evolving applications. Diabetes Care. 2014 Apr;37(4):900-5. doi: 10.2337/dc13-1990.
- Background: PubMed 12626762Eells JT, Henry MM, Summerfelt P, Wong-Riley MT, Buchmann EV, Kane M, Whelan NT, Whelan HT. Therapeutic photobiomodulation for methanol-induced retinal toxicity. Proc Natl Acad Sci U S A. 2003 Mar 18;100(6):3439-44. doi: 10.1073/pnas.0534746100. Epub 2003 Mar 7.
- Background: PubMed 22045511Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2.
- TORPA Study of Photobiomdulation for AMDLink provided by the sponsor.
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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.
Judy Kim, MD principal investigator
MCW Dept of Ophthalmology
Sandeep Gopalakrishnan, Ph.D. principal investigator
UW-Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 670nm PBM and intravitreous VEGF-inhibitors in people with Diabetic Retinopathy, run by Medical College of Wisconsin 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Sep 2019. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity as assessed by the Early Treatment of Diabetic Retinopathy Study (EDTRS) Classification (time frame: Change from baseline at 8 weeks; Change from baseline at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457975, which also lists 9 linked publications.
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 10 Sep 2019.