CompletedPhase 2

High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia

United States6 participantsStarted 2010-10

Plain-language summary

Idiopathic Parafoveal Telangiectasia (IPT) \[also known as Idiopathic Perifoveal Telangiectasia, Idiopathic Juxtafoveal Telangiectasia (IJT, JFT) and Macular Telangiectasia (MacTel)\] is a disorder of unknown etiology. IPT is classified as Group 2A in the Gass classification of macular telangiectasias (Reference 1,5) - a bilateral, but not always symmetric disorder. It is characterized in its early stages by dilation and loss of parafoveal capillaries accompanied by angiographic leakage, "right angle" venules, central and parafoveal intraretinal cysts.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age \> 18 years * Presence of nonproliferative IPT confirmed by fluorescein angiography and spectral-domain OCT * Age greater than 18 * Vision equal to or worse than 20/25 and better than or equal to 20/400 by ETDRS chart, without co-existing choroidal neovascularization. * Physical ability and reasonable expectation to maintain all follow-up appointments. Exclusion Criteria: * Pregnancy (positive pregnancy test) or lactation * Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * Participation in another simultaneous ophthalmologic investigation or trial * Any patient with proliferative diabetic retinopathy, diabetic macular edema, uveitis, history of ocular trauma, severe glaucoma, neovascular age-related macular degeneration * Duration of previous treatment of IPT that exceeds two years. * Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could eith…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Acuity Change From Baseline to Month 12 of the Study

Timeframe: Baseline to 12 months

Trial details

NCT IDNCT01205035

SponsorEye Center of Northern Colorado, P.C.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2015-03-18

View on ClinicalTrials.gov More Retinal Diseases trials