---
title: Proton Radiation Therapy for Macular Degeneration
nct_id: NCT01833325
overall_status: COMPLETED
phase: NA
sponsor: University of Florida
study_type: INTERVENTIONAL
primary_condition: Age-Related Macular Degeneration
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01833325.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01833325"
ct_last_update_post_date: 2018-02-23
last_seen_at: "2026-05-12T06:48:49.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Proton Radiation Therapy for Macular Degeneration

**Official Title:** A Pilot Study to Assess the Safety of Proton Therapy for Subfoveal Neovascularization Associated With Age-Related Macular Degeneration

**NCT ID:** [NCT01833325](https://clinicaltrials.gov/study/NCT01833325)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 9
- **Lead Sponsor:** University of Florida
- **Conditions:** Age-Related Macular Degeneration
- **Start Date:** 2013-05
- **Completion Date:** 2018-02
- **CT.gov Last Update:** 2018-02-23

## Brief Summary

This is a pilot study to determine if proton radiation therapy can provide effective and safe treatment for subfoveal neovascularization membrane (SNVM). The study will include adult patients over the age of 50 with macular degeneration, who have subfoveal neovascularization membrane (SNVM) and have had prior treatment with Avastin or Lucentis. Additional purposes of this study are to see if the growth of neovascular membranes can be stopped and overall vision improved with the use of protons and assess the side effects associated with this treatment.

## Detailed Description

As part of this study, participants will have had a standard of care comprehensive eye exam by an Ophthalmologist to include visual acuity, fundus photography, fluorescein angiography and optical coherence tomography prior to treatment.

Participants will receive radiation using protons for 2 consecutive days. Each treatment will take 30 minutes. They will receive a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments. A total of 10 participants will be enrolled on this study.

A comprehensive eye exam by an Ophthalmologist will be performed 30 days after radiation treatment with protons. Additionally, a physical examination per a Radiation Oncologist including a toxicity evaluation and comprehensive eye exam by an Ophthalmologist will be performed every 3 months for 1 year following radiation treatment.

## Eligibility

- **Minimum age:** 50 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients with subfoveal neovascular membranes identified on fluorescein angiography.
* Visual acuity (best corrected vision) 20/200 or worse in affected eye.
* Patient must be 50 years of age or older at time of consent.
* Patients must have had prior treatment for macular degeneration with Avastin (bevacizumab) or Lucentis (ranibizumab).
* Women must be post menopausal or have had a hysterectomy.

Exclusion Criteria:

* History of diabetes.
```

## Arms

- **Proton radiation** (EXPERIMENTAL) — Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments

## Interventions

- **Proton radiation** (RADIATION) — Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments

## Primary Outcomes

- **Number of participants with acute and late morbidity of the eye as a measure of safety** _(time frame: 1 year after completion of radiation treatment)_
- **Number of participants with cessation of growth of neovascular membranes.** _(time frame: 1 year after completion of radiation treatment)_
- **Visual acuity per comprehensive eye exam** _(time frame: 1 year after completion of radiation treatment)_
- **Frequency of intravitreal injections following radiation treatment** _(time frame: 1 year after completion of radiation treatment)_

## Locations (1)

- University of Florida Proton Therapy Institute, Jacksonville, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of florida proton therapy institute|jacksonville|florida|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01833325.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01833325*  
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