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Age-related Macular DegenerationPhase 2NCT04486963

A Phase Ⅱ Clinical Study of Sanhuangjingshimingwan in Wet( Neovascular)Age-related Macular Degeneration(wAMD) Subjects

A Phase 2 study testing Sanhuangjingshimingwan in people with Age-related Macular Degeneration, run by Tasly Pharmaceutical Group Co., Ltd at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan in Wet AMD. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Age-related Macular Degeneration
What is being tested?
Sanhuangjingshimingwan
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
6 sitesChina
Study dates
24 Jul 2020to 15 Nov 2022
Phase
Phase 2
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must meet the following criteria for entry into the trail:
  • Meet the diagnostic criteria for wAMD.
  • Meet the Traditional Chinese Medicine diagnostic criteria for Qi and Yin Deficiency, Phlegm-blood Stasis Syndrome.
  • Presence of choroidal neovascularization secondary to wAMD, and/or simple eye with blood, edema, leakage, hard exudation in or below the retina, and detachment of retinal pigment epithelium or neuroepithelium epithelium.
  • 50 years≤Age≤80 years of either gender.
  • BCVA 25 - 78 ETDRS letters(0.06~0.6, inclusive).
  • Signed informed consent form.

Who cannot join

  • Subjects who meet any of the following criteria will be excluded from study entry:
  • Presence of pathological myopia,high myopia caused of secondary choroidal neovascularization, glaucoma, diabetic retinopathy, retinal arteriovenous obstruction, optic neuropathy (optic neuritis, atrophy, papillary edema), macular hole, acute phase of intraocular inflammation.
  • Only retinal pigment epithelium-retinal detachment.
  • The CNV area is more than 12 optic disk area (30mm2).
  • Subfoveal structural damage or fibrosis.
  • Subjects that have unclear refractive stroma(e.g.vitreous hemorrhage, cataracts) caused fundus observation difficulty or undergone vitrectomy.
Show all 17Show fewer
  • Subjects that have presence of other causes of choroidal neovascularization.
  • Subjects that have participated in other study of treatment with study drug within the last 3 months before the screening.
  • Subjects that have treated with photodynamic therapy, external beam radiological therapy, argon laser photocoagulation in macular area, macular surgery, transpupillary thermotherapy, hormone to treat wAMD in any eye within the last 6 months before the screening.
  • Subjects that have undergone previous any eye surgery(except eyelid surgery).
  • Subjects that have intravitreal anti-VEGF injections in the past 3 months.
  • Subjects with history of fundus fluorescein and indocyanine green allergy.
  • Subjects that have any contraindications in the directions of ranibizumab(LUCENTIS)injection.
  • Subjects that have had severe heart disease in the last 6 months,such as congestive heart failure，unstable angina，acute coronary syndrome，myocardial infarction，Coronary revascularization，artery thrombosis, and ventricular arrhythmia that need treatment.
  • Subjects with uncontrolled hypertension（After antihypertension treatment SBP≥140mmHg、DBP≥90mmHg）.
  • PLT≤100×109/L; Coagulation function disorders;TBIL（Total Bilirubin）>1.5×UNL（Upper Limits of Normal）;ALT（Alanine Transaminase）>2.5×UNL or AST（Aspartate aminotransferase）>2.5×UNL;Cr（Creatinine）>1.5×UNL.
  • Subjects with uncontrolled disease history, such as serious mental, neurological, respiratory, immune, blood and other system diseases, malignant tumors and that not suitable for the study per the investigator's judgment.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Tianjin Eye Hospital

    Tianjin, Tianjin Municipality

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Ranibizumab Injected, Multicenter Phase II Clinical Study on the Efficacy and Safety of Sanhuangjingshimingwan in the Wet AMD(Qi and Yin Deficiency, Phlegm-blood Stasis Syndrome )Subjects

The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan in Wet AMD.

Read the detailed description

The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan,give two times a day versus placebo in wAMD .The clinical phase of the study comprises a 6-months double-blind treatment period, resulting in 6.5-months overall duration of the study for each patient.

Being tested
Sanhuangjingshimingwan, Sanhuangjingshimingwan Placebo
Keywords
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.

  • SanhuangjingshimingwanDrug

    Sanhuangjingshimingwan,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.

  • Sanhuangjingshimingwan PlaceboDrug

    Sanhuangjingshimingwan Placebo,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.

Study groups in NCT04486963
Study groupRoleWhat they receive
Sanhuangjingshimingwan groupExperimentalSanhuangjingshimingwan,12g/bag,1 bag,Bid.Anti VEGF injection will be injected monthly if needed.
Receives: Drug: Sanhuangjingshimingwan
Sanhuangjingshimingwan Placebo groupPlacebo comparatorSanhuangjingshimingwan placebo,12g/bag,1 bag,Bid.Anti VEGF injection will be injected monthly if needed.
Receives: Drug: Sanhuangjingshimingwan Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The average number of reinjections

    The subject is injected with Anti-VEGF（Vascular Endothelial Growth Factor） injection once 4 weeks if needed.Compare with the average shoot number of Anti-VEGF injections in both arms.

    Measured: at week 24

Secondary outcomes (12)

  1. The percentage of subjects in both arms receiving reinjection of Anti-VEGF injection

    The subject is injected with Anti-VEGF injection once weeks if needed.Compare with the percentage of subjects who reinjected Anti-VEGF injections in both arms.

    Measured: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

  2. The average number of days between the second injection and baseline injection

    The subject is injected with Anti-VEGF injection once 4 weeks if needed.Compare with the average number of days between the second injection and baseline injection in both arms.

    Measured: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

  3. Change from baseline in BCVA

    The subject is tested the vision(BCVA) once 4 weeks with ETDRS visual chart.Compare every visit BCVA with baseline BCVA.

    Measured: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

  4. The BCVA increasing >5, >10 and > 15 letters change from baseline

    The proportion of subjects who increased BCVA >5, >10 and > 15 letters at each visit compared with the baseline.

    Measured: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

  5. The BCVA decreasing<5, <10 and < 15 letters change form baseline

    The proportion of subjects who decreased BCVA <5, <10 and <15 letters at each visit compared with the baseline.

    Measured: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

  6. The BCVA decreasing≥15, ≥30 letters change form baseline

    The proportion of subjects who decreased BCVA ≥15, ≥30 letters at 24 week compared with the baseline.

    Measured: at week 24

  7. Change from Baseline in Central Retinal Thickness (CRT)

    Change from Baseline in CRT as measured by Optical Coherence Tomography (OCT) over the study duration.

    Measured: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

  8. Change from Baseline in Choroidal Neovascularization (CNV) area

    Change from Baseline in CNV area as measured by Optical Coherence Tomography Angiography(OCTA) over the study duration.

    Measured: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

  9. Change from Baseline in leakage area

    Change from Baseline in leakage area as measured by Fluorescein Angiography (FA) at week 24.

    Measured: at week 24

  10. Change from Baseline in the number of polypoid choroidal vasculopathy(PCV) and Branching vascular network(BVN) area

    Change from Baseline in the number of PCV and BVN area as measured by Indocyanine Green Angiography(ICGA) over the study duration.

    Measured: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

  11. Change from Baseline in TCM(Traditional Chinese Medicine) syndrome scores

    The title of the scale is Traditional Chinese Medicine Syndrome Scale.Compared wth baseline,the scores of changes of TCM syndrome evaluation at each visit .This scale consists of two primary symptoms: Blurred vision and Metamorphopsia,and four secondary symptoms.Four levels to measure severity of primary symptoms（0、2、4、6）and secondary symptoms（0、1、2、3） respectively. The final score has a range of 0（none）to 42（severe）.TCM syndrome effect calculated by nimodipine method.The effect of TCM syndrome from negative (worsen) to 100% (disappear).

    Measured: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

  12. Change from Baseline in the effective TCM syndrome scores

    The title of the scale is Traditional Chinese Medicine Syndrome Scale.Compared wth baseline,the scores of changes of TCM syndrome evaluation at each visit .This scale consists of two primary symptoms: Blurred vision and Metamorphopsia,and four secondary symptoms.Four levels to measure severity of primary symptoms（0、2、4、6）and secondary symptoms（0、1、2、3） respectively. The final score has a range of 0（none）to 42（severe）.TCM syndrome effect calculated by nimodipine method.The effect of TCM syndrome from negative (worsen) to 100% (disappear).

    Measured: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study start24 Jul 2020
  3. Primary completion1 Nov 2022
  4. Study completion15 Nov 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04486963
Sponsor's protocol ID
TSL-TCM-SHJSMW-IIa
Status last verified
Nov 2022
First submitted
22 Jul 2020
Last updated
25 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sanhuangjingshimingwan in people with Age-related Macular Degeneration, run by Tasly Pharmaceutical Group Co., Ltd at 6 sites 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 17 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 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The average number of reinjections (time frame: at week 24). 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 NCT04486963.

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 25 Nov 2022.

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