BridgeMD
A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema
EU CTIS ID: 2023-507207-66-00
What this study is testing
To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in subjects with Diabetic macular edema (DME).
- Therapeutic confirmatory (Phase III)
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
- Signed informed consent form before any study-specific procedures are performed.
- Male or female adult subject aged 18 to 85 years.
- 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).
- BCVA ETDRS letters score >35 letters (>20/200 Snellen equivalent) in the non-study eye at screening (ie, as per definition of monocular blindness).
- 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).
- Documented diagnosis of Type 1 or Type 2 diabetes mellitus and an HbA1c of ≤ 10.0% prior to screening (Visit 1) (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]).
You likely can't join if
- 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.
- 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.
- Use of systemic corticosteroids (ie, oral, IM, IV, intranasal) within 1 month prior to Day 1 and no systemic corticosteroids anticipated throughout the study.
- Any prior or concomitant systemic anti-VEGF treatment within 6 months prior to Day 1.
- 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.
- Decrease in BCVA because of causes other than DME.
See the full eligibility criteria
Who can join
- Signed informed consent form before any study-specific procedures are performed.
- Male or female adult subject aged 18 to 85 years.
- 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).
- BCVA ETDRS letters score >35 letters (>20/200 Snellen equivalent) in the non-study eye at screening (ie, as per definition of monocular blindness).
- 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).
- Documented diagnosis of Type 1 or Type 2 diabetes mellitus and an HbA1c of ≤ 10.0% prior to screening (Visit 1) (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]).
- Anti-vascular endothelial growth factor (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
- 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).
What rules you out
- 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.
- 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.
- Use of systemic corticosteroids (ie, oral, IM, IV, intranasal) within 1 month prior to Day 1 and no systemic corticosteroids anticipated throughout the study.
- Any prior or concomitant systemic anti-VEGF treatment within 6 months prior to Day 1.
- 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.
- Decrease in BCVA because of causes other than DME.
- Known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
- 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.
- Active or suspected periocular or ocular infection in the study eye. Mild noninfectious blepharitis is accepted.
- History of noninfectious uveitis in the study eye.
- 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).
- Subjects who plan to continue using contact lenses (including cosmetic contact lenses) during the study in the study eye.
- Subjects with high-risk proliferative diabetic retinopathy (PDR) as per CRC assessment at screening (Visit 1) only.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- India
- United States
- Korea, Republic of
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 Canada; India; United States; Korea, Republic of. 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.