NCT02864472

Brief Summary

The aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2016

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

August 4, 2016

Last Update Submit

August 10, 2016

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Change in central retinal thickness

    Change in central retinal thickness measured by OCT

    after 6month

Secondary Outcomes (1)

  • Change of ETDRS BCVA

    after 6month

Study Arms (2)

combination Tx

OTHER

combination Tx(vPDT +ranibizumab) (M0) + ranibizumab PRN (M3-6)

Procedure: PDTDrug: ranibizumab PRN

mono Tx

OTHER

Ranibizumab (at 4 weeks interval) \*3 (M0-2) + ranibizumab PRN (M3-6)

Drug: RanibizumabDrug: ranibizumab PRN

Interventions

PDTPROCEDURE

PDT and ranibizumab

combination Tx
RanibizumabDRUG

Ranibizumab

Also known as: Lucentis
mono Tx
ranibizumab PRNDRUG

ranibizumab PRN

Also known as: Lucentis
combination Txmono Tx

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age equal to or older than 50 years
  • Insufficient responder to ranibizumab Tx
  • ICGA-confirmed PCV
  • BCVA letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study

You may not qualify if:

  • Prior treatment with other anti-VEGF treatments in the study eye.
  • Prior treatment with other anti-VEGF treatments within 3 months prior to Visit 1 in the non-study eye.
  • Prior treatment with verteporfin within 6 months prior to Visit 1 in the study eye.
  • Prior treatment with verteporfin within 7 days prior to Visit 1 in the non-study eye.
  • Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
  • Previous submacular surgery in the study eye
  • A history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia
  • Experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma
  • Previous participation in a clinical trial involving anti-angiogenic drugs
  • Intraocular surgery: 2 months before Visit 1 in the study eye.
  • Previous participation in any studies of investigational drugs
  • Administration of periocular, intravitreal, or systemic corticosteroid in the previous 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1. Wong RLM et al. J Ophthalmol Vis Res 2013;8:359-71. 2. Koh A et al. Retina 2013;33:686-716 3. Nakashizuka H et al. Invest Ophthalmol Vis Sci 2008;49:4729-37 4. Gomi F, Tano Y Curr Opin Ophthalmol 2008;19:208-12 5. Honda S et al. Ophthalmologica 2014;231:59-74 6. Maruko E et al. Am J Ophthalmol 2007;144:15-22 7. Byeon S et al. Jpn J Ophthalmol 2008;52:57-62 8. Uyama M et al. Am J Ophthalmol 2002;133:639-48

    RESULT

MeSH Terms

Conditions

Macular Degeneration

Interventions

1-phenyl-3,3-dimethyltriazeneRanibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jangwon Heo, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jangwon Heo, MD

CONTACT

82-2-2072-2438hjw68@snu.ac.kr

Serang Choi, MD

CONTACT

82-2-2072-2953icaol@hanmail.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 12, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2018

Study Completion

January 1, 2019

Last Updated

August 12, 2016

Record last verified: 2016-08