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Macular EdemaPhase 4NCT03908307

Evaluation of OZURDEX® in Patients With Macular Edema Secondary to Retinal Vein Occlusion in China

A Phase 4 study testing OZURDEX in people with Macular Edema and Retinal Vein Occlusion, run by Allergan at 9 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

This study will take place in China to evaluate the safety and efficacy of OZURDEX implant 700 μg in the treatment of macular edema due to retinal vein occlusion (RVO) in patients who have never received treatment for RVO. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Edema, Retinal Vein Occlusion
What is being tested?
OZURDEX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
9 sitesChina
Study dates
25 Jul 2019to 26 Sep 2021
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient diagnosed with macular edema due to RVO (either BRVO or CRVO, non-ischemic)
  • Retinal thickness ≥ 300 μm by SD-OCT in the central 1 mm macular subfield of the study eye at the Screening visit
  • BCVA score of 19 to 73 letters (approximately 20/400 to 20/40 Snellen equivalent) in the study eye measured by ETDRS method at Screening
  • < 3 months of macular edema duration
  • Treatment-naive patients (ie, have not previously received any treatment for macular edema secondary to RVO)

Who cannot join

  • Uncontrolled systemic disease
  • Presence of/history of any ocular condition other than macular edema that affects visual acuity (eg, cataract, severe macular ischemia, foveal atrophy, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, prior macular detachment)
  • Any of the following ≤ 3 months before study entry or anticipated need within the coming 3 months:
  • Intraocular surgery
  • Laser photocoagulation
  • Intraocular injection
Show all 19Show fewer
  • Periocular steroid injection
  • Vitrectomized eye
  • Aphakic eyes with ruptured posterior lens capsule or presence of an ACIOL, iris or transscleral fixated intraocular lens
  • History of marked IOP elevation in response to steroid treatment that (a) required IOP-lowering treatment, (b) resulted in a >10 mm Hg increase in IOP from predose, or (c) resulted in IOP >25 mm Hg
  • History of glaucoma or ocular hypertension (IOP > 21 mm Hg), or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in the study eye (patients with a history of previous angle closure that has been successfully treated with either a laser or surgical peripheral iridotomy [PI] are allowed as long as the visual fields have been stable for > 1 year prior to study entry and the patient has been and can be safely dilated).
  • Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at the Screening visit
  • Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
  • Any condition that may interfere or preclude participation in the study
  • Use of systemic steroids (e.g., oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to Baseline or anticipated use at any time during the study (inhaled, intranasal, and intra-articular/intrabursal corticosteroids are allowed)
  • Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to Baseline or anticipated use at any time during the study
  • Use of warfarin or heparin within 2 weeks prior to Baseline or anticipated use within the study period
  • Known allergy, hypersensitivity or contraindication to the study medication, its components, fluorescein or povidone iodine
  • Current enrollment in another drug or device study within 30 days prior to Baseline

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Peking Union Medical College Hospital /ID# 233616

    Beijing, Beijing Municipality, 100730

  • Beijing Tongren Hospital, CMU /ID# 233608

    Beijing, 100730

  • The First Xiangya Hospital of Central South University /ID# 233627

    Changsha Hunan, 410008

  • The First Affiliated Hospital of Dalian Medical University /ID# 233688

    Dalian, 116011

  • Qilu Hospital of Shandong University /ID# 233605

    Jinan, 250012

  • The Eye and ENT Hospital Affiliated of Fudan Univesity /ID# 233666

    Shanghai, 200031

  • Shanghai General Hospital /ID# 233579

    Shanghai, 200080

  • Joint Shantou International Eye Center of Shantou University and The Chinese Uni /ID# 233580

    Shantou, 515041

  • Tianjin Eye Hospital /ID# 233581

    Tianjin, 300020

Other trials in China

About this study

Official title: A 12-month, Open-label, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® Implant 700 µg (Dexamethasone) on Patients With Macular Edema Secondary to Retinal Vein Occlusion in China (YANGTZE Study)

This study will take place in China to evaluate the safety and efficacy of OZURDEX implant 700 μg in the treatment of macular edema due to retinal vein occlusion (RVO) in patients who have never received treatment for RVO.

Being tested
OZURDEX
Medical subject headings
Macular Edema, Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OZURDEXDrug

    Implant 700 μg

Study groups in NCT03908307
Study groupRoleWhat they receive
Study EyeExperimentalOZURDEX implant 700 μg
Receives: Drug: OZURDEX

What is being measured

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

  1. Mean change in visual acuity from Baseline

    Determined by best corrected visual acuity (BCVA)

    Measured: At Month 6

  2. Proportion of patients with a BCVA improvement of 15 letters or more compared to Baseline

    Measured using the ETDRS visual acuity protocol

    Measured: At Month 6

  3. BCVA average change from Baseline in area under the curve (AUC) analysis

    Measured: At Month 6

Secondary outcomes (10)

  1. Mean change from Baseline in BCVA

    Measured: After first follow-up visit, at each injection, and at Month 12

  2. Mean change from Baseline in Central Retinal Thickness (CRT)

    Measured: At Months 6 and 12

  3. Mean change from Baseline in the National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25

    25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Original numeric values from the survey will be recoded with the worst and best possible scores set at 0 and 100 points, respectively. In this format, scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.

    Measured: At Months 6 and 12

  4. Mean number of OZURDEX injections

    Measured: During the 12-month study

  5. Mean retreatment interval in months

    Measured: During the 12-month study

  6. Proportion of patients with 2nd injection

    Measured: During the 12-month study

  7. Proportion of patients with 3rd injection

    Measured: During the 12-month study

  8. Time to 2nd injection

    Measured: During the 12-month study

  9. Time to 3rd injection

    Measured: During the 12-month study

  10. Correlation between the change of BCVA and extent of leak by fluorescein angiography (FA)

    Measured: At Month 6

Timeline

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

  1. First posted9 Apr 2019
  2. Study start25 Jul 2019
  3. Primary completion26 Sep 2021
  4. Study completion26 Sep 2021

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03908307
Sponsor's protocol ID
CMO-MA-EYE-0575
Status last verified
Mar 2023
First submitted
28 Mar 2019
Last updated
31 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OZURDEX in people with Macular Edema and Retinal Vein Occlusion, run by Allergan at 9 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 5 inclusion and 19 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Mean change in visual acuity from Baseline (time frame: At Month 6). The study lists 3 primary outcomes in all. 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 NCT03908307.

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 31 Mar 2023.

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