InflammationPhase 3NCT06429306
Study of Dexycu in Treating Intraocular Inflammation
A Phase 3 study testing Dexycu in people with Inflammation and Cataract, run by Ocumension Therapeutics (Shanghai) Co., Ltd at 1 site in China.
Trial summary
This is a phase III, prospective, randomised, double-masked, placebo-controlled, parallel-design, multicenter study of the efficacy, safety and pharmacokinetics of 9% dexamethasone intraocular injection for the treatment of inflammation associated with cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Inflammation, Cataract
- What is being tested?
- Dexycu
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2022to 9 Apr 2024
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
- Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
- The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye and better than 20/200 in the fellow eye.
- The patient must be considered by the Investigator to have visual acuity potential. greater than 20/30 in the study eye.
- The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
- A female patient of childbearing potential must have a negative pregnancy test on Day 0 and be using an effective method of birth control from Screening for the duration of the study.
- The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.
Who cannot join
- Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
- Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
- Patients who have received any intravitreal corticosteroid delivery vehicle (e.g.,Retisert, Ozurdex, Iluvien) in the study eye at any time.
- Patients who anticipate requiring treatment with any corticosteroids( by any route,except inhalation), during the study.
- Patients with an allergy or hypersensitivity to dexamethasone.
- Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
Show all 18Show fewer
- Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
- Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
- Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
- Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
- Patients with any signs of intraocular inflammation in either eye at screening.
- Patients with evidence of corneal abnormality or dystrophy (e.g. opacities, guttae,clouding, etc.) or an inability to obtain an acceptable specular micrograph at Screening.
- Patients with a history of chronic uveitis from any cause in either eye.
- Patients who have received any prior intravitreal injections in the study eye.
- Patients with glaucomatous optic neuropathy or glaucomatous visual field loss in either eye.
- Patients with ocular hypertension with an IOP in the study eye > 21 mm Hg at Screening with or without treatment with anti-glaucoma monotherapy.
- Patients with ocular hypertension receiving treatment with two or more anti-glaucoma Medications.
- Patients treated with any investigational product within 30 days prior to screening or patients enrolled previouslyc study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3,Prospective, Randomized, Double-masked, Placebo-controlled, Parallel Study to Evaluate the Efficacy, PK and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associatedwith Cataract Surgery
This is a phase III, prospective, randomised, double-masked, placebo-controlled, parallel-design, multicenter study of the efficacy, safety and pharmacokinetics of 9% dexamethasone intraocular injection for the treatment of inflammation associated with cataract surgery.
Read the detailed description
This is a prospective, randomized, double-blindmasked, placebo-controlled, parallel- design, multicenter study of subjects over 40 years undergoing cataract surgery. Subjects meet the inclusion criteria and do not meet any exclusion criteria are randomiszed to the dexamethasone implant group or placebo group at a ratio of 2:1.
Subjects received a single does injection in the study eye immediately after the completion of cataract surgery. The investigational drug comes with a special injection device and injection guide.
All subjects will be administered to the study eye with quinolone topical antibiotic eye drops or their equivalent 3 days before and 7 days after surgery.
- Conditions
- Inflammation, Cataract
- Being tested
- Dexycu, Placebo
- Keywords
- Cataract Surgery, Postoperative Inflammation
- Medical subject headings
- Inflammation, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexycuDrug
Also called Investigational product
5ul dexamethasone, concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone
PlaceboDrug
Acetyl triethyl citrate
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone intraocular injection | Experimental | Dexamethasone implant single injection in the treatment eye after cataract surgery. Receives: Drug: Dexycu |
| Placebo | Placebo comparator | Blank placebo single injection in the treatment eye after cataract surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior chamber cell clearing rate
The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
Measured: DAY 8
Secondary outcomes (5)
Anterior chamber cell clearing rates
The secondary efficacy outcome is anterior chamber cell clearing in the study eye at Day 1 \& 3 \& 15 \& 30. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
Measured: DAY 1 & 3 & 15 & 30
Anterior chamber flare clearing rates
Percentage of subjects with anterior chamber flare grade 0 at Day 1, 3, 8, 15, and 30. The slit lamp examination for anterior chamber flare (ACF) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent), grade 1 (trace), grade 2 (mild intensity), grade 3 (moderate intensity), or grade 4 (strong intensity). Anterior chamber flare clearing occurs when all the ACC are absent (grade 0).
Measured: DAY 1 & 3 & 8 & 15 & 30
Anterior chamber cell & flare clearing rates
The secondary efficacy outcome is anterior chamber cell \& flare clearing in the study eye at Day 1 \& 3 \& 15 \& 30. The slit lamp examination for anterior chamber cells \& flare (ACCF) is a recognized way to measure inflammation in the anterior chamber.
Measured: DAY 1 & 3 & 15 & 30
Mean anterior chamber cell score and mean anterior chamber flare score
Calculate the mean score of anterior chamber cell and flare separately at Day 8 and 15.
Measured: DAY 8 & 15
Mean anterior chamber cell + flare score
Calculate the mean socre of anterior chamber cell + flare at Day 8 and 15.
Measured: DAY 8 &15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start22 Aug 2022
- Primary completion24 Nov 2023
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocumension Therapeutics (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhixun Li, Study director, Ocumension Therapeutics (Shanghai) Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429306
- Sponsor's protocol ID
- OT-502-001
- Status last verified
- Aug 2024
- First submitted
- 11 May 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3,Prospective, Randomized, Double-masked, Placebo-controlled, Parallel Study to Evaluate the Efficacy, PK and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associatedwith Cataract Surgery
- ClinicalTrials.gov ID
- NCT06429306
- Acronym / sponsor ID
- OT-502-001
- Conditions
- Inflammation, Cataract
- Keywords
- Cataract Surgery, Postoperative Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Ocumension Therapeutics (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 24 May 2024 (actual)
- 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 III, prospective, randomised, double-masked, placebo-controlled, parallel-design, multicenter study of the efficacy, safety and pharmacokinetics of 9% dexamethasone intraocular injection for the treatment of inflammation associated with cataract surgery.
Detailed description
This is a prospective, randomized, double-blindmasked, placebo-controlled, parallel- design, multicenter study of subjects over 40 years undergoing cataract surgery. Subjects meet the inclusion criteria and do not meet any exclusion criteria are randomiszed to the dexamethasone implant group or placebo group at a ratio of 2:1.
Subjects received a single does injection in the study eye immediately after the completion of cataract surgery. The investigational drug comes with a special injection device and injection guide.
All subjects will be administered to the study eye with quinolone topical antibiotic eye drops or their equivalent 3 days before and 7 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone intraocular injection | Experimental | Drug: DexycuDexamethasone implant single injection in the treatment eye after cataract surgery. |
| Placebo | Placebo comparator | Drug: PlaceboBlank placebo single injection in the treatment eye after cataract surgery. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
- Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
- The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye and better than 20/200 in the fellow eye.
- The patient must be considered by the Investigator to have visual acuity potential. greater than 20/30 in the study eye.
- The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
Key exclusion criteria (18 listed)
- Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
- Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
- Patients who have received any intravitreal corticosteroid delivery vehicle (e.g.,Retisert, Ozurdex, Iluvien) in the study eye at any time.
- Patients who anticipate requiring treatment with any corticosteroids( by any route,except inhalation), during the study.
- Patients with an allergy or hypersensitivity to dexamethasone.
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 |
|---|---|---|
| DexycuAlso: Investigational product5ul dexamethasone, concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone | Drug | Dexamethasone intraocular injection |
| PlaceboAcetyl triethyl citrate | Drug | Placebo |
Primary outcome
Anterior chamber cell clearing rate
Time frame: DAY 8
The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
5 secondary outcomes
Anterior chamber cell clearing rates
Time frame: DAY 1 & 3 & 15 & 30
Anterior chamber flare clearing rates
Time frame: DAY 1 & 3 & 8 & 15 & 30
Anterior chamber cell & flare clearing rates
Time frame: DAY 1 & 3 & 15 & 30
Mean anterior chamber cell score and mean anterior chamber flare score
Time frame: DAY 8 & 15
Mean anterior chamber cell + flare score
Time frame: DAY 8 &15
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 26 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Zhixun Li study director
Ocumension Therapeutics (Shanghai) Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexycu in people with Inflammation and Cataract, run by Ocumension Therapeutics (Shanghai) Co., Ltd at 1 site in China.
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 7 inclusion and 18 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 26 Aug 2024. 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 China. 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Anterior chamber cell clearing rate (time frame: DAY 8). 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 26 Aug 2024.