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Wet Macular DegenerationPhase 4NCT02944227

Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration

A Phase 4 study testing Lucentis in people with Wet Macular Degeneration, run by Seoul National University Hospital at 1 site in South Korea.

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 objective of this pilot study is to evaluate the efficacy of intensive fixed monthly dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor) monotherapy. Read more about this study

Who is it for?
Any age
Conditions the study is for
Wet Macular Degeneration
What is being tested?
Lucentis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSouth Korea
Study dates
3 Mar 2016to 21 Aug 2017
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Age equal to or older than 50 years.
  • Presence of SRF associated with PED in neovascular AMD (proven with OCT FA, and ICG) which is persistent despite consecutive anti-VEGF injections for at least 9 months (3 initial loading doses with 4 week interval followed by PRN regimen)
  • A "persistent PED" is defined as a subject with < 50% reduction or increase in PED height

Who cannot join

  • Administration of periocular, intravitreal, or systemic corticosteroid within 3 months prior to visit 1 in the study eye
  • Prior treatment with photodynamic therapy in the study eye
  • Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
  • Previous submacular surgery in the study eye
  • History of vitrectomy in the study eye
  • Epiretinal membranes (ERM)
  • Submacular hemorrhage or fibrosis within 50% of entire PED.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Efficacy of Fixed Monthly Dosing of Lucentis® (Ranibizumab) on Subretinal Fluid (SRF) Associated With Persistent Pigment Epithelial Detachment (PED) in Neovascular Age-related Macular Degeneration (AMD): A Pilot Study

The objective of this pilot study is to evaluate the efficacy of intensive fixed monthly dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor) monotherapy.

Read the detailed description

PEDs occur in up to 62% of eyes with advanced AMD. Numerous treatment options have been employed for PEDs in AMD, including laser therapies and intravitreal injections of anti-VEGF antibodies. However, eyes with PEDs were excluded from the larger clinical trials that used macular laser, photodynamic therapy, or ranibizumab to treat neovascular AMD; therefore, the efficacy of such options is still unclear for eyes with PEDs in neovascular AMD. Additionally, PED lesions have been reported to show less morphological and functional response to anti-VEGF monotherapy than eyes with other CNV lesions subtypes.

Based on the generally poor prognosis of PEDs and the lack of sufficient data in the literature regarding the effectiveness of fixed monthly dosing of Lucentis® (Ranibizumab) therapy, the investigators designed a prospective study to evaluate the effect of intensive fixed monthly dosing of Ranibizumab for the treatment of SRF associated with PED in neovascular AMD which is persistent to previous anti-VEGF monotherapy.

Being tested
Lucentis
Medical subject headings
Wet Macular Degeneration

What participants receive

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

  • LucentisDrug

    Also called Ranibizumab

    Lucentis fixed-treatment arm

Study groups in NCT02944227
Study groupRoleWhat they receive
LucentisExperimentalLucentis fixed treatment
Receives: Drug: Lucentis

What is being measured

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

  1. Changes of a pigment epithelial detachment (PED)

    Maximum height

    Measured: Baseline and 6 months

  2. Changes of a pigment epithelial detachment (PED)

    Maximum diameter

    Measured: Baseline and 6 months

  3. Changes of subretinal fluid (SRF)

    Maximum height

    Measured: Baseline and 6 months

  4. Changes of subretinal fluid (SRF)

    Maximum diameter

    Measured: Baseline and 6 months

Secondary outcomes (9)

  1. Change in best corrected visual acuity from baseline

    Measured: Baseline and 6 months

  2. Changes in subfoveal thickness (SFT) measured by optical coherence tomography (OCT) from baseline

    Measured: Baseline and 6 months

  3. The proportion of cases maintaining vision and also who gained ≥ 15 letters from baseline

    Measured: Baseline and 6 months

  4. The proportion of cases having complete resolution of SRF associated with serous pigment epithelial detachment (PED)

    Measured: Baseline and 6 months

  5. The proportion of cases having complete resolution of subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED)

    Measured: Baseline and 6 months

  6. The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with serous pigment epithelial detachment (PED)

    Measured: Baseline and 6 months

  7. The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED)

    Measured: Baseline and 6 months

  8. The incidence of ocular adverse events

    Measured: Through study completion, an average of 1 year

  9. The proportion of cases experiencing leakage from neovascular AMD lesions

    Measured: Baseline and 6 months

Timeline

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

  1. First posted25 Oct 2016 (estimated)
  2. Study start3 Mar 2016
  3. Primary completion16 Feb 2017
  4. Study completion21 Aug 2017

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02944227
Sponsor's protocol ID
H-1512-107-728
Status last verified
Apr 2018
First submitted
16 Feb 2016
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Chan CK, Abraham P, Sarraf D, Nuthi AS, Lin SG, McCannel CA. Earlier therapeutic effects associated with high dose (2.0 mg) Ranibizumab for treatment of vascularized pigment epithelial detachments in age-related macular degeneration. Eye (Lond). 2015 Jan;29(1):80-7. doi: 10.1038/eye.2014.233. Epub 2014 Oct 3.

    PubMed 25277305

  • Ersoy L, Ristau T, Kirchhof B, Liakopoulos S. Response to anti-VEGF therapy in patients with subretinal fluid and pigment epithelial detachment on spectral-domain optical coherence tomography. Graefes Arch Clin Exp Ophthalmol. 2014 Jun;252(6):889-97. doi: 10.1007/s00417-013-2519-9. Epub 2013 Nov 26.

    PubMed 24271025

  • Iordanous Y, Powell AM, Mao A, Hooper PL, Eng KT, Schwartz C, Kertes PJ, Sheidow TG. Intravitreal ranibizumab for the treatment of fibrovascular pigment epithelial detachment in age-related macular degeneration. Can J Ophthalmol. 2014 Aug;49(4):367-76. doi: 10.1016/j.jcjo.2014.05.010.

    PubMed 25103655

  • Arora S, McKibbin M. One-year outcome after intravitreal ranibizumab for large, serous pigment epithelial detachment secondary to age-related macular degeneration. Eye (Lond). 2011 Aug;25(8):1034-8. doi: 10.1038/eye.2011.115. Epub 2011 May 20.

    PubMed 21597485

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lucentis in people with Wet Macular Degeneration, run by Seoul National University Hospital at 1 site in South Korea.

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 4 inclusion and 7 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 19 Apr 2018. 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 South Korea. 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?

Changes of a pigment epithelial detachment (PED) (time frame: Baseline and 6 months). The study lists 4 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 NCT02944227, which also lists 4 linked publications.

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 19 Apr 2018.

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