BridgeMD
A Phase 2/3 Double-masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema
EU CTIS ID: 2023-507208-30-00
What this study is testing
Stage 1: To select a dosing regimen for OCS-01 in subjects with diabetic macular edema (DME). Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in subjects with DME.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Stage 1- 1) Have a signed informed consent form before any study-specific procedures are performed
- Stage 1- 4) Participants require Best Corrected Visual Acuity (BCVA) ETDRS letter score >34 letters (>20/200 Snellen equivalent) in the non–study eye at screening (as per definition of monocular blindness)
- Stage 1- 5) Have an BCVA ETDRS letter score ≤ 65 (Snellen 20/50) and ≥ 24 (Snellen 20/320) in the study eye at screening and baseline (Visit 1 and Visit 2)
- Stage 1- 6) Have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% (≤108 mmol/mol) at Visit 1 (Screening)
- Stage 1- 7) Participants who have been treated with any antivascular endothelial growth factor (VEGF) agents intravitreally (IVT) and/or corticosteroids periocular or IVT in the study eye in the past and for whom the following washout periods before Day 1 would apply: a. Anti-VEGF agents IVT: 3 months b. Periocular or IVT corticosteroids: i. Triamcinolone: 4 months; ii. Biodegradable slow-release steroid IVT implant (eg, Ozurdex): 6 Months; iii. Nonbiodegradable slow-release steroid implant (eg, Iluvien, Retisert, Yutiq): 3 years Clarification: For inclusion criteria 7 and 8, each subject must meet one criterion or the other
- Stage 1- 8)Participants who are anti-VEGF and corticosteroid IVT treatment-naïve (ie, have not received previous treatment with any anti-VEGF and corticosteroid IVT) in the study eye.
You likely can't join if
- Have macular edema considered to be because of a cause other than Diabetic macular edema (DME). Note: an eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction;(2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (eg, a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema, or (3) the macular edema is considered to be related to another condition such as age-related macular degeneration, uveitis, retinal vein occlusion, or drug toxicity. If the DME consists of circumscribed, focal leakage that the evaluating Investigator believes should be treated with laser and no other treatments, the eye is not eligible to be a study eye.
- Any prior or concomitant systemic anti-VEGF treatment within 6 months before Day 1.
- Significant medical conditions that in the opinion of the Investigator may affect the subject compliance with study visits.
- Have a decrease in Best Corrected Visual Acuity (BCVA) because of causes other than DME (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, nonretinal condition, substantial cataract, macular ischemia) that, in the Investigator's opinion, is likely to be decreasing BCVA by 3 lines or more (ie, cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal) in the study eye.
- Female participants must not be pregnant or breastfeeding.
- WOCBP who are not able to comply with adequate birth control throughout the study period.
See the full eligibility criteria
Who can join
- Stage 1- 1) Have a signed informed consent form before any study-specific procedures are performed
- Stage 1- 4) Participants require Best Corrected Visual Acuity (BCVA) ETDRS letter score >34 letters (>20/200 Snellen equivalent) in the non–study eye at screening (as per definition of monocular blindness)
- Stage 1- 5) Have an BCVA ETDRS letter score ≤ 65 (Snellen 20/50) and ≥ 24 (Snellen 20/320) in the study eye at screening and baseline (Visit 1 and Visit 2)
- Stage 1- 6) Have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% (≤108 mmol/mol) at Visit 1 (Screening)
- Stage 1- 7) Participants who have been treated with any antivascular endothelial growth factor (VEGF) agents intravitreally (IVT) and/or corticosteroids periocular or IVT in the study eye in the past and for whom the following washout periods before Day 1 would apply: a. Anti-VEGF agents IVT: 3 months b. Periocular or IVT corticosteroids: i. Triamcinolone: 4 months; ii. Biodegradable slow-release steroid IVT implant (eg, Ozurdex): 6 Months; iii. Nonbiodegradable slow-release steroid implant (eg, Iluvien, Retisert, Yutiq): 3 years Clarification: For inclusion criteria 7 and 8, each subject must meet one criterion or the other
- Stage 1- 8)Participants who are anti-VEGF and corticosteroid IVT treatment-naïve (ie, have not received previous treatment with any anti-VEGF and corticosteroid IVT) in the study eye.
- Stage 2- 1) Have a signed informed consent form before any study-specific procedures are performed
- Stage 1- 9) Have a negative urine pregnancy test at Visit 1, if women of childbearing potential (WOCBP) those who have experienced menarche and who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or postmenopausal [12 months after last menses]) and must use adequate birth control throughout the study period (refer to Appendix 2 of the protocol).
- Stage 2- 8) Negative urine pregnancy test at Visit 1, if WOCBP (those who have experienced menarche and who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or postmenopausal [12 months after last menses]) and must use adequate birth control throughout the study period (refer to Section 18.2 Appendix 2 of the protocol).
- Stage 2- 2) Be a male or female adult subject age 18 to 85 years.
- Stage 2- 3) DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (to be confirmed by CRC); CST is not part of the eligibility reconfirmation on Day 1 (Visit 2).
- Stage 2- 4) BCVA ETDRS letters score >35 letters (>20/200 Snellen equivalent) in the non-study eye at screening (ie, as per definition of monocular blindness).
- Stage 2- 5) BCVA ETDRS letters score ≤65 (Snellen 20/50) and ≥24 (Snellen 20/320) in the study eye at screening and baseline (Visit 1 and Visit 2).
- Stage 2- 6) Documented diagnosis of Type 1 or Type 2 diabetes mellitus and an HbA1c of ≤ 10.0% prior to Visit 1 (Screening) (Historic values of HbA1c taken up to 2 months before the screening visit will be permissible otherwise the study site will collect a sample for analysis at screening [Visit 1]).
- Stage 2- 7) Anti-VEGF and corticosteroid IVT treatment-naïve (ie, have not received previous treatment with any anti-VEGF and corticosteroid IVT) in the study eye, OR treated with anti-VEGF agents IVT and/or corticosteroids IVT in the study eye in the past and for whom the following washout periods before Day 1 apply: a. Anti-VEGF agents IVT: 3 months b. Periocular or IVT corticosteroids: i. Triamcinolone: 4 months ii. Biodegradable slow-release steroid IVT implant (eg, Ozurdex): 6 months iii. Nonbiodegradable slow-release steroid implant (eg, Iluvien, Retisert, Yutiq): 3 years
- Stage 1- 2) Be a male or female adult subject age 18 to 85 years. Race and ethnicity information will be collected based on National Institutes of Health criteria
- Stage 1- 3) Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310μm (may be adjusted based on gender specific requirements) by Spectral domain optical coherence tomography (SD-OCT) at screening (V1) (as assessed by an independent reading center); CST is not part of the eligibility reconfirmation on Day 1
What rules you out
- Have macular edema considered to be because of a cause other than Diabetic macular edema (DME). Note: an eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction;(2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (eg, a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema, or (3) the macular edema is considered to be related to another condition such as age-related macular degeneration, uveitis, retinal vein occlusion, or drug toxicity. If the DME consists of circumscribed, focal leakage that the evaluating Investigator believes should be treated with laser and no other treatments, the eye is not eligible to be a study eye.
- Any prior or concomitant systemic anti-VEGF treatment within 6 months before Day 1.
- Significant medical conditions that in the opinion of the Investigator may affect the subject compliance with study visits.
- Have a decrease in Best Corrected Visual Acuity (BCVA) because of causes other than DME (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, nonretinal condition, substantial cataract, macular ischemia) that, in the Investigator's opinion, is likely to be decreasing BCVA by 3 lines or more (ie, cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal) in the study eye.
- Female participants must not be pregnant or breastfeeding.
- WOCBP who are not able to comply with adequate birth control throughout the study period.
- History of chronic renal failure that requires dialysis or kidney transplant.
- Stage 2- 1) Macular edema considered to be because of a cause other than DME. Examples included the macular edema is considered to be related to ocular surgery, clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease, acute macular degeneration (AMD), retinal vein occlusion (RVO), uveitis.
- Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
- Have any other ocular disease that may cause substantial reduction in BCVA, including, retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis involving the macula in the study eye, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases.
- Have active or suspected periocular or ocular infection in the study eye (eg, keratitis, scleritis, or conjunctivitis). Mild noninfectious blepharitis is accepted.
- History of glaucoma and/or steroid induced elevated IOP in either eye.
- Have a history of noninfectious uveitis in the study eye.
- History of herpetic ocular disease in the study eye.
- Hazy ocular media in the study eye, as assessed by the Investigator, that may affect fundus examination and OCT measurements.
- Intraocular pressure (IOP) more than 21 mm Hg at Screening in the study eye (glaucoma suspects).
- Stage 2- 2) Decrease in BCVA because of causes other than DME.
- Stage 2- 3) Known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
- Stage 2- 4) Any other ocular disease in the study eye that may cause substantial reduction in BCVA, including retinal detachment, vitreomacular traction, epiretinal membrane, vitreous hemorrhage or fibrosis involving the macula, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases.
- Stage 2- 5) Active or suspected periocular or ocular infection in the study eye. Mild noninfectious blepharitis is accepted.
- Stage 2- 6) History of noninfectious uveitis in the study eye.
- Stage 2- 7) Uncontrolled ocular hypertension or glaucoma in either eye, defined as IOP >22 mmHg while on more than 1 IOP-lowering medication at screening (Visit 1).
- Cup to disc ratio more than 0.5 in either eye.
- Stage 2- 8) Subjects who plan to continue using contact lenses (including cosmetic contact lenses) during the study in the study eye.
- Stage 2- 9) Subjects with high-risk proliferative diabetic retinopathy (PDR) as per CRC assessment at screening (Visit 1) only.
- Stage 2- 10) Currently enrolled in or have participated in any other clinical study involving a study drug or device, or in any other type of medical research, within 30 days before screening and up to completion of the current study.
- Stage 2- 11) Use of systemic corticosteroids (ie, oral, IM, IV, intranasal) within 1 month prior to screening (Visit 1) and no systemic corticosteroids anticipated throughout the study.
- Stage 2- 12) Any prior or concomitant systemic anti-VEGF treatment within 6 months prior to Day 1.
- Stage 2- 13) Any other medical condition that in the opinion of the investigator may affect BCVA, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study.
- Subjects who plan to continue using contact lenses as a main source of vision correction during the study in the study eye.
- Subjects who plan to use cosmetic contact lenses in the study eye during the study.
- History of major intraocular ocular surgery within 3 months including cataract surgery in the study eye.
- Panretinal photocoagulation in the study eye; OR grid laser within 1000 microns of the foveal center in the study eye.
- Participants who are currently enrolled in or have participated in any other clinical study involving a study drug or device, or in any other type of medical research, within 30 days before screening and up to completion of the current study.
- Systemic corticosteroids (prednisone or methylprednisolone) either oral or injectable are not allowed in the study. The use of acute inhaled corticosteroids is permissible during the study for up to 14 days.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.