Age-related Wet Macular DegenerationPhase 1NCT06132035
Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration
A Phase 1 study testing CG-P5 peptide and Aflibercept Injection [Eylea] in people with Age-related Wet Macular Degeneration, run by Caregen Co. Ltd. at 7 sites in United States.
Trial summary
This will be a randomized, comparative, parallel, clinical study to assess initial safety and tolerability of CG-P5 peptide eye drops compared to placebo in patients diagnosed with age-related wet macular degeneration Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Wet Macular Degeneration
- What is being tested?
- CG-P5 peptide and Aflibercept Injection [Eylea]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Dec 2023to Aug 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥50 years of age
- Willing and able to provide written informed consent
- Diagnosis of age-related wet macular degeneration (wAMD) in the study eye as determined by the investigator on fundus examination
- Primary or recurrent active choroidal neovascularization (CNV) lesions involving the foveal center secondary to age-related wet macular degeneration in any one of the eyes. (If both eyes are affected and eligible, the eye with the worse BCVA, as assessed at screening, will be selected as the study eye
- Best corrected visual acuity (BCVA) of 75-25 eye Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (approximate Snellen equivalent between 20/ 32 to 20/320) inclusive before pupil dilation assessed at the initial testing distance of 4 meters
- Central Subfield Thickness (CST thickness) ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
Show all 13Show fewer
- Presence of SRF and/or IRF on SD-OCT
- Total lesion size not greater than 12 disc areas (30.48 mm2) (1 disc area = 2.54 mm2) on FA
- If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA, SD-OCT, or FAF
- No subfoveal fibrosis or atrophy on FA, SD-OCT, or FAF
- Active CNV membranes with subfoveal leakage or juxtafoveal leakage too close for laser photocoagulation
- Females who are of non-childbearing potential (surgically sterile or menopausal) OR if of childbearing potential using effective birth control and non-pregnant \& non-lactating
- Ability to follow protocol requirements
Who cannot join
- Patients having additional eye disease in the posterior segment of study eye other than wAMD
- Any other pathology involving the CNV lesion like retro foveolar atrophy or permanent structural damage to fovea or fibrosis/ hemorrhage involving fovea > 50 % of lesion area of study eye that can affect the efficacy of drug
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tear involving the macula or macular hole (stage 3 or 4) in the study eye
- Aphakia or absence of the posterior capsule in the study eye
- History or expectation of the following surgery in the study eye:
- Vitrectomy within last 1 month
Show all 33Show fewer
- Cataract surgery or Lasik within the last 3 months
- Planned cataract removal surgery during the study
- A history or medical diagnosis of uncontrolled glaucoma (defined as IOP >25mmHg even with anti-glaucoma medication), advanced glaucoma resulting in a cup/disc ratio >0.8 in the study eye, or glaucoma filtration surgery in the study eye
- Serious complications following surgery in the study eye within 1 year
- Current or planned use of medications known to be toxic to the retina, lens, or optic nerve (e.g., deferoxamine, chloroquine/hydro chloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol)
- Medical history or condition: Uncontrolled diabetes mellitus, with glycosylated hemoglobin (HbA1c) > 10%, myocardial infarction or stroke within 12 months of screening, active bleeding disorder, major surgery within 1 month of screening or when planned within the study period, hepatic impairment, uncontrolled hypertension, other unstable or progressive cardiovascular, pulmonary, Parkinson, liver, or renal disease or cancer or dementia
- Previous treatment with intravenous bevacizumab or intravitreal ranibizumab, bevacizumab, aflibercept, pegaptanib in either of the eyes within four months prior to enrolment
- Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser, transpupillary thermotherapy, intravitreal or protein kinase C inhibitors or other AMD therapy in the study eye within 3 months prior to randomization
- Previous treatment with intravitreal ocular or periocular steroids (e.g., triamcinolone, anecortave acetate) or peribulbar steroid in the study eye within past 3 months
- Concurrent use of systemic anti-VEGF agents
- Any ophthalmic device implantation within the previous 12 months
- Patients with a clinically significant abnormal screening hematology, blood chemistry, or urinalysis, unsuitable for study participation in the investigator's opinion
- Aspartate Transaminase (AST), Alanine Transaminase (ALT), alkaline phosphatase, Gamma-glutamyl Transferase (GGT), total bilirubin, direct bilirubin, indirect bilirubin, and LDH ≥ 2.0-fold the upper limit of normal at screening
- Patient with impaired renal function defined as calculated creatinine clearance (CLCr) <30mL/min
- Males: CLCr = [140 - a(years)] x weight(kg)/ 72 x serum creatinine (mg/dL)
- Females: CLCr = [140 - a(years)] x weight(kg) (x 0.85)/ 72 x serum creatinine (mg/dL)
- Significant alcohol or drug abuse within past 2 years per investigator judgement
- Previous participation in other trials for treatment of wAMD with systemic administration if washout period from last administration is shorter than 3 months
- Significant disease or other medical conditions (as determined by medical history, examination, and clinical investigations at screening) that may, in the opinion of the investigator result in the any of the following:
- Put the patient at risk because of participation in the study,
- Influence the results of the study,
- Cause concern regarding the patient's ability to participate in the study
- Known hypersensitivity to fluorescein or any of the ingredients used in the study drug formulation, or any of the medications used during the study
- Active infectious conjunctivitis in either eye
- Women of childbearing potential who are lactating or who are pregnant as determined by serum pregnancy test at screening
- Women of childbearing potential must have agreed to use adequate birth control methods for the duration of the study
- Post-menopausal women should have documented last MC 2 years before study participation
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eldho Jose contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
CBCC Global Research Site:001
Augusta, Georgia, 30909
- Recruiting
CBCC Global Research Site:004
Carmel, Indiana, 46290
- Recruiting
CBCC Global Research Site:006
Deerfield Beach, Florida, 33064
- Recruiting
CBCC Global Research Site:002
Erie, Pennsylvania, 16507
- Recruiting
CBCC Global Research Site:003
Fargo, North Dakota, 58104
- Recruiting
CBCC Global Research Site:005
Manchester, Connecticut, 06042
- Recruiting
CBCC Global Research Site:007
Philadelphia, Pennsylvania, 19141
About this study
Official title: Phase I Clinical Study to Evaluate the Safety of CG-P5 Peptide Eye Drops (Self-administered and Topically Applied) in Patients Diagnosed With Age-related Wet Macular Degeneration
This will be a randomized, comparative, parallel, clinical study to assess initial safety and tolerability of CG-P5 peptide eye drops compared to placebo in patients diagnosed with age-related wet macular degeneration
- Conditions
- Age-related Wet Macular Degeneration
- Being tested
- CG-P5 peptide, Placebo, Aflibercept Injection [Eylea]
- Keywords
- Age-Related Macular Degeneration, Macular Degeneration, wAMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-P5 peptideDrug
Patient will instill daily 1 package of CG-P5 peptide eye drops in the study eye [self-administered] using the single use tear-off disposable packaging
PlaceboDrug
Patient will instill daily 1 package of Placebo eye drops in the study eye [self-administered] using the single use tear-off disposable packaging
Aflibercept Injection [Eylea]Drug
Patient will receiver Eylea® (Aflibercept) intravitreal injection once in a month
| Study group | Role | What they receive |
|---|---|---|
| CG-P5 peptide eye drops | Experimental | Not described Receives: Drug: CG-P5 peptide |
| Placebo Eye drops | Placebo comparator | Not described Receives: Drug: Placebo |
| Intravitreal injection of Eylea® | Active comparator | Not described Receives: Drug: Aflibercept Injection [Eylea] |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of occurrence of Adverse Events (AE)
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
The number of Adverse Events (AE) that occurs
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Change in IOP with study drug compared to placebo
Mean change in intraocular pressure (IOP) with study drug compared to placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Change in intraocular inflammation with study drug compared to placebo
Mean change in intraocular inflammation with study drug compared to placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Incidence and severity of ocular and non-ocular adverse events of CG-P5 peptide eye drops and Placebo
Mean change in incidence and severity of ocular and non-ocular adverse events of CG-P5 peptide eye drops and Placebo with study drug compared to placebo from baseline to end of study
Measured: Day 0, Day 28, Day 56 & Day 84
Secondary outcomes (20)
Change in best corrected visual acuity (BCVA) of study drug compared to Eylea® and placebo as measured by ≥15 Early ETDRS letter score at the end of 84 days
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Change in CNV area on fluorescence angiography with study drug compared to Eylea® and placebo on day 28, day 56 and day 84
Measured: Day 28, Day 56 & Day 84
Mean decrease in central retinal thickness on SD-OCT with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Mean decrease in total macular volume on optical coherence tomography with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in BCVA with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in BCVA with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in intraocular pressure (IOP) with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in intraocular pressure (IOP) with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in intraocular inflammation with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in intraocular inflammation with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in central retinal thickness with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in central retinal thickness with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in total macular volume with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in total macular volume with study drug compared to Eylea® and placebo from baseline to end of study
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Change from Baseline in Choroidal Neovascularization (CNV) area as measured by Fluorescein Angiography (FA) over the study duration
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Change from Baseline in Central Subfield Thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) over the study duration
Measured: Screening, Day 0, Day 28, Day 56 & Day 84
Area under the concentration-time curve from dosing (time 0) to time t [AUC(0-t)]
Pharmacokinetic profile of CG-P5 peptide eye drops measured by AUC(0-t)
Measured: Day 0 & Day 84
Maximum Plasma Concentration [Cmax]
Pharmacokinetic profile of CG-P5 peptide eye drops measured by Cmax
Measured: Day 0 & Day 84
Time of peak plasma concentration [Tmax]
Pharmacokinetic profile of CG-P5 peptide eye drops measured by Tmax
Measured: Day 0 & Day 84
Half-life [t½]
Pharmacokinetic profile of CG-P5 peptide eye drops measured by t½
Measured: Day 0 & Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start22 Dec 2023
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Wet Macular DegenerationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caregen Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Responsible party
- Sponsor
- Investigators
- Dr. Yong Ji Chung, Study director, Caregen Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132035
- Sponsor's protocol ID
- CG_P5_2023W1
- Status last verified
- Feb 2025
- First submitted
- 24 Oct 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety of CG-P5 Peptide Eye Drops (Self-administered and Topically Applied) in Patients Diagnosed With Age-related Wet Macular Degeneration
- ClinicalTrials.gov ID
- NCT06132035
- Acronym / sponsor ID
- CG_P5_2023W1
- Conditions
- Age-related Wet Macular Degeneration
- Keywords
- Age-Related Macular Degeneration, Macular Degeneration, wAMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Caregen Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 15 Nov 2023 (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 will be a randomized, comparative, parallel, clinical study to assess initial safety and tolerability of CG-P5 peptide eye drops compared to placebo in patients diagnosed with age-related wet macular degeneration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CG-P5 peptide eye drops | Experimental | Drug: CG-P5 peptide |
| Placebo Eye drops | Placebo comparator | Drug: Placebo |
| Intravitreal injection of Eylea® | Active comparator | Drug: Aflibercept Injection [Eylea] |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female patients ≥50 years of age
- Willing and able to provide written informed consent
- Diagnosis of age-related wet macular degeneration (wAMD) in the study eye as determined by the investigator on fundus examination
- Primary or recurrent active choroidal neovascularization (CNV) lesions involving the foveal center secondary to age-related wet macular degeneration in any one of the eyes. (If both eyes are affected and eligible, the eye with the worse BCVA, as assessed at screening, will be selected as the study eye
- Best corrected visual acuity (BCVA) of 75-25 eye Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (approximate Snellen equivalent between 20/ 32 to 20/320) inclusive before pupil dilation assessed at the initial testing distance of 4 meters
Key exclusion criteria (33 listed)
- Patients having additional eye disease in the posterior segment of study eye other than wAMD
- Any other pathology involving the CNV lesion like retro foveolar atrophy or permanent structural damage to fovea or fibrosis/ hemorrhage involving fovea > 50 % of lesion area of study eye that can affect the efficacy of drug
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tear involving the macula or macular hole (stage 3 or 4) in the study eye
- Aphakia or absence of the posterior capsule in the study eye
- History or expectation of the following surgery in the study eye:
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 |
|---|---|---|
| CG-P5 peptidePatient will instill daily 1 package of CG-P5 peptide eye drops in the study eye [self-administered] using the single use tear-off disposable packaging | Drug | CG-P5 peptide eye drops |
| PlaceboPatient will instill daily 1 package of Placebo eye drops in the study eye [self-administered] using the single use tear-off disposable packaging | Drug | Placebo Eye drops |
| Aflibercept Injection [Eylea]Patient will receiver Eylea® (Aflibercept) intravitreal injection once in a month | Drug | Intravitreal injection of Eylea® |
Primary outcome
The percentage of occurrence of Adverse Events (AE)
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
The number of Adverse Events (AE) that occurs
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Change in IOP with study drug compared to placebo
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Mean change in intraocular pressure (IOP) with study drug compared to placebo from baseline to end of study
Change in intraocular inflammation with study drug compared to placebo
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Mean change in intraocular inflammation with study drug compared to placebo from baseline to end of study
Incidence and severity of ocular and non-ocular adverse events of CG-P5 peptide eye drops and Placebo
Time frame: Day 0, Day 28, Day 56 & Day 84
Mean change in incidence and severity of ocular and non-ocular adverse events of CG-P5 peptide eye drops and Placebo with study drug compared to placebo from baseline to end of study
20 secondary outcomes
Change in best corrected visual acuity (BCVA) of study drug compared to Eylea® and placebo as measured by ≥15 Early ETDRS letter score at the end of 84 days
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Change in CNV area on fluorescence angiography with study drug compared to Eylea® and placebo on day 28, day 56 and day 84
Time frame: Day 28, Day 56 & Day 84
Mean decrease in central retinal thickness on SD-OCT with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Mean decrease in total macular volume on optical coherence tomography with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in BCVA with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in BCVA with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in intraocular pressure (IOP) with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in intraocular pressure (IOP) with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in intraocular inflammation with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in intraocular inflammation with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in central retinal thickness with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in central retinal thickness with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in total macular volume with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in total macular volume with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Change from Baseline in Choroidal Neovascularization (CNV) area as measured by Fluorescein Angiography (FA) over the study duration
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Change from Baseline in Central Subfield Thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) over the study duration
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Area under the concentration-time curve from dosing (time 0) to time t [AUC(0-t)]
Time frame: Day 0 & Day 84
Maximum Plasma Concentration [Cmax]
Time frame: Day 0 & Day 84
Time of peak plasma concentration [Tmax]
Time frame: Day 0 & Day 84
Half-life [t½]
Time frame: Day 0 & Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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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.
Eldho Jose contact
Dr. Yong Ji Chung study director
Caregen Co. Ltd.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CG-P5 peptide and Aflibercept Injection [Eylea] in people with Age-related Wet Macular Degeneration, run by Caregen Co. Ltd. at 7 sites 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 13 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ishita Trivedi (+1- 609-594-6709, ishita.trivedi@cbcc.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of occurrence of Adverse Events (AE) (time frame: Screening, Day 0, Day 28, Day 56 & Day 84). The study lists 5 primary outcomes in all. 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 7 Feb 2025.