Clinical Trials in Retinopathy of Prematurity (ROP)

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Early Treatment for Retinopathy of Prematurity (ETROP)

Arch Ophthalmol 2003;121:1684 | Trans Am Ophthalmol Soc 2004;102:233 | Arch Ophthalmol 2006;124:24 | Br J Ophthalmol 2006;128:663 | Arch Ophthalmol 2010;128:663.

Objectives

The goal was to determine if early treatment with laser in retinopathy of prematurity (ROP) in high-risk eyes improves visual and anatomical outcomes and the grades most likely to benefit.

Design

Prospective clinical trial inclulding infants with a birth weight less than 1251 grams. Infants with bilateral high‐risk pre threshold ROP had one eye randomly assigned to laser treatment with peripheral retinal ablation. The fellow eye was managed conventionally, and either treated at threshold ROP or observed if threshold was never reached. In patients with asymmetrical disease, the high‐risk, prethreshold eye was randomised to earlier treatment or to conventional management. These infants were examined every fortnight, beginning at four to six weeks of age.

Inclusion criteria were pre-threshold ROP defined as 1) Zone 1, any stage (when less than threshold) 2) Zone 2, stage 2 with plus disease 3) Zone 2, stage 3 (when less than threshold).

Main outcome measures

Failure of treatment, defined as unfavourable structural outcome (1) a posterior retinal fold involving the macula, (2) a retinal detachment involving the macula or (3) retrolental tissue or “mass” obscuring the view of the posterior pole.

Results

From 2000 to 2002, Data were available on 339 of 374 (90.6%) surviving children. Unfavourable structural outcomes were reduced from 15.4% in conventionally managed eyes to 9.1% in earlier laser-treated eyes. There were no side effects.

Conclusions

The benefit of earlier laser treatment of high‐risk prethreshold ROP on retinal structure, and has no side effects. Furthermore, earlier treatment improves the chance for long‐term favourable retinal structural outcomes in eyes with high‐risk prethreshold ROP.

Pearls for clinical practice

Earlier laser treatment is beneficial on high‐risk prethreshold ROP.


Bevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity (BEATROP) 2008

Arch Ophthalmol 2008;126:1161 | N Engl J Med 2011;364:603.

Objectives

The goal was to determine if anti-VEGF would help retinopathy of prematurity and which grades would most likely benefit. A randomised clinical trial was performed to compare intravitreal anti-VEGF to conventional laser therapy for ROP.

Design

Prospective, controlled, randomized, stratified, multicenter trial. Infants with a birth weight less than 1500 grams or a gestational age of less than 30 weeks were recruited and randomised to receive bilateral bevacizumab monotherapy (0.625 mg in 0.025 ml) vs. conventional laser therapy.

These infants were examined beginning at four weeks or 31 weeks of post-menstrual age (whichever was later).

The inclusion criteria were stage 3+ disease in zone 1 or posterior zone 2, and bilateral involvement.

Main outcome measures

Failure of treatment, defined as recurrence of neovascularisation in one or both eyes arising from the retinal vessels requiring re-treatment by 54 weeks age.

Results

From 2008 to 2010, 150 infants were randomised to receive bilateral bevacizumab monotherapy (0.625 mg in 0.025 ml) vs. conventional laser therapy. Bevacizumab injection could be repeated based on the ophthalmologist’s discretion. Retinopathy of prematurity recurred in 4 infants in the bevacizumab group (4%) and 19 infants in the laser group (22%). In the bevacizumab group, a significant treatment effect was found for zone I retinopathy of prematurity but not for zone II disease

Limitations

The failure rate of laser treatment in this study was higher than in the ETROP study. If a similar success rate with laser had been achieved, it is less likely that the results for Zone 1 disease would have been significant. The study was not powered to assess safety outcomes, but 71% of the infant deaths in this study occurred in the bevacizumab group.

Conclusions

Bevacizumab is effective in the treatment of stage 3+ ROP in Zone 1 and posterior Zone 2. 2. Bevacizumab is no better than laser for reducing the recurrence rate of posterior Zone 2 disease but was shown to be superior for Zone 1 disease. The development of peripheral retinal vessels continued after treatment with intravitreal bevacizumab; however conventional laser therapy permanently destroyed the peripheral retina avoiding the appearance of vessels.

Pearls for clinical practice

Bevacizumab is effective in the treatment of stage 3+ ROP in Zone 1 and posterior Zone 2.

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