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OpenTrials
Completed

NCT Number: NCT00680498

Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment

This is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group).

The combination treatment group will receive ranibizumab, followed 1 week later by verteporfin PDT. Additional treatments will be based on evidence of active disease (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed monthly, and repeat PDT will be allowed every 3 months.

The control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. Ranibizumab injections will be given at baseline and months one and two. Additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, OCT and FA criteria.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Illinois Retina Associates

Oak Park, Illinois, 60304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of subfoveal CNV due to AMD, less than 9 disc areas in extent
  • Vision 20/40 to 20/800 Snellen equivalent
  • Age > 50 years
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study

Exclusion criteria

  • Intraocular surgery or injection within 30 days prior to enrollment in the study eye
  • Intravitreal triamcinolone within the past 6 months in the study eye
  • History of prior PDT treatment in the study eye
  • History of argon laser treatment of subfoveal CNV in the study eye
  • Other vision-limiting disease (e.g. advanced glaucoma, prior vascular occlusion, dense amblyopia) in the study eye
  • Clinically significant intraocular inflammation in the study eye
  • No light perception in the fellow eye
  • Anterior segment opacity preventing adequate visualization of fundus for FA or OCT
  • Are currently participating in another clinical trial
  • Women of childbearing potential not using adequate contraception, as well as women who are breastfeeding
  • Known sensitivity to study drug(s) or class of study drug(s)
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  • Use of any other investigational agent in the last 30 days

Treatment and study plan

ranibizumab

Drug

Ranibizumab 0.5 mg

Other names: Lucentis

Ranibizumab plus Photodynamic therapy

Drug

Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)

Other names: Lucentis, Visudyne

Primary outcomes

  1. To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.

    Time frame: 1 year

Secondary outcomes

  1. Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.

    Time frame: 1 year

  2. Determination of change in visual acuity from baseline.

    Time frame: 1 year

  3. Determination of change in retinal thickness by optical coherence tomography (OCT).

    Time frame: 1 year

  4. Determination of change in angiographic leakage from CNV.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Illinois Retina Associates

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Acronym: CLOVER

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 20, 2008
Registry last updated
Mar 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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